U.S. Unveils First 10 Drugs for Medicare Price Negotiations

 The Centers for Medicare & Medicaid Services (CMS) took a historic step forward in its plans to negotiate the prices of Medicare's most costly prescription drugs by naming the first 10

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The list of drugs to be negotiated includes:

• Apixaban (Eliquis): a blood thinner used to prevent stroke and blood clots
• Empagliflozin (Jardiance): a drug used to treat type 2 diabetes and heart failure
• Rivaroxaban (Xarelto): a blood thinner used to treat and prevent blood clots and reduce risks for patients with coronary or peripheral artery disease
• Sitagliptin (Januvia): a drug for treating type 2 diabetes
• Dapagliflozin (Farxiga): a drug for treating type 2 diabetes, heart failure, and chronic kidney disease
• Sacubitril/valsartan (Entresto): a drug for patients with chronic heart failure
• Etanercept (Enbrel): a drug for moderate to severe rheumatoid arthritis
• Ibrutinib (Imbruvica): a drug that is used to treat chronic lymphocytic leukemia/small lymphocytic lymphoma
• Ustekinumab (Stelara): a biologic that treats Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis
• Insulin aspart injection (NovoLog, among others): a drug for patients with diabetes mellitus

"For far too long, Americans have paid more for prescription drugs than any major economy. And while the pharmaceutical industry makes record profits, millions of Americans are forced to choose between paying for medications they need to live or paying for food, rent, and other basic necessities. Those days are ending," said President Biden in a press release.

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A 2003 law that expanded Medicare's prescription drug coverage also blocked CMS from negotiating drug prices. Under the landmark 2022 Inflation Reduction Act (IRA)opens in a new tab or window, CMS gained that authority for the first time.

"Today, my administration announced the first 10 Medicare Part D drugs that have been selected for price negotiation -- for the first time ever," Biden said. "We've reached this milestone because of the Inflation Reduction Act -- one of the most significant laws ever enacted, and one that passed with the leadership of Democrats in Congress."

Once implemented, the negotiated prices will lower costs for up to 9 million seniors, currently paying up to $6,497 in out-of-pocket costs annually for their medications, the president noted.

On top of the savings for seniors, the Congressional Budget Office estimates that the combined negotiation provisions and inflation rebate provisions of the IRA -- drugmakers must pay rebates to the federal government if they hike their prices above the level of inflation -- will save taxpayers $160 billion through reductions to Medicare spending.

The negotiations are slated to begin in 2023 and continue in 2024. Negotiated prices would then take effect at the start of 2026. Already, pharmaceutical companies and other industry players have filed as many as eight lawsuits to try to block or delay the negotiations from advancing, and more are expected.

The First Drugs Chosen for Negotiation

The 10 drugs chosen by CMS -- single-source brand-name drugs with no therapeutically equivalent generic or biosimilar competition -- were targeted for negotiation based on their total expenditures in the Medicare Part D program. These drugs are either costly, widely used, or both.

In terms of total Medicare Part D costs over the last year (June 2022 to May 2023), apixaban cost the most, at $16.5 billion for the 3.7 million enrollees taking the medication (total cost of $4,448 per enrollee). This was followed by empagliflozin ($7.1 billion), rivaroxaban ($6.0 billion), and sitagliptin ($4.1 billion).

The highest cost per enrollee went to ibrutinib ($133,178, with 20,000 enrollees over the previous year), followed by ustekinumab ($119,951, with 22,000 enrollees), and etanercept ($58,148, for 48,000 enrollees).

To be eligible for negotiation, drugs must be 7 years out from their FDA approval or licensure date for small-molecule drugs, or 11 years out for biologics, as of the date that the selected drugs list is published.

Senior administration officials, who spoke on background during a press call on Tuesday morning, said CMS "selected the 10 highest-spending drugs that qualify under the process that was described in the statute and the CMS program instruction."

The agency first identified the qualifying drugs under Medicare Part D as having been on the market for 7 to 11 years without competition, an official explained. Some drugs were excluded, including certain orphan drugs, low-spend drugs, or plasma-derived products.

"From there, we identified and ranked the top 50 qualifying single-source drugs with the highest gross costs to Medicare Part D, to determine the list of negotiation-eligible drugs ... and then finally from that, CMS selected the 10 highest-ranked negotiation-eligible drugs," the official said.

For the most part, experts said they anticipated that most of the drugs selected would be up for negotiation.

There were a "couple surprises," however, said Kelsey Lang, a principal in health policy at Avalere, a healthcare consulting firm based in the Washington, D.C.-Baltimore area. She attributed discrepancies between experts' predictions and the agency's list to differences in the data used in each of their analyses.

Dapagliflozin, sacubitril/valsartan, and ustekinumab seem to have jumped in spending, based on public data, which made them eligible for negotiation, she told MedPage Today in a phone interview during which a press representative was present.

Richard Frank, PhD, a senior fellow and director of the Brookings Schaeffer Initiative on Health Policy at the Brookings Institution, noted that "there are a bunch of drugs that have been on the market for a long time that have carried super high prices and have made tons of money, and I think those are the candidates where you can give taxpayers and consumers a real break, without really threatening the profitability of the product."

Apixaban has had global sales of $91 billion since it launched in 2013, he said. Even factoring in the cost of development -- roughly $3.5 billion -- there is still a significant amount of money to be made, he pointed out.

Adalimumab (Humira), an expensive biologic used to treat plaque psoriasis, was one drug some experts thought might be chosen for negotiation. A biosimilar adalimumab-atto (Amjevita)opens in a new tab or window launched in January, but has not seen a great deal of uptake.

Frank suspects CMS saw "enough potential for competition that they kept it off the list."

A senior administration official on the press call said that "any of the drugs that you might have expected to see on the list that aren't selected here could be selected in future years under the exact same process."

Asked what impact price negotiations would have for patients, Madelaine Feldman, MD, vice president of advocacy and government affairs for the Coalition of State Rheumatology Organizations, told MedPage Today that patients often tend not to reap the benefits of drug pricing reforms.

However, because drug price negotiation has been paired with a $2,000 cap on annual out-of-pocket spending, expected to take effect in 2025, she said she is more optimistic.

"Someone's going to have to make up that difference that the patients used to pay," she said. And because much of the burden has shifted to Part D plans, they may be more incentivized to start putting lower priced drugs on their formularies, she added.

What Happens Next?

This fall, CMS will invite drug companies whose drugs have been selected for negotiation to meet with the agency regarding their data submissions. The agency will also host patient-focused listening sessions on the selected drugs.

Drug companies selected for the program will have until October 1 to sign an agreement to participate in the negotiation process for 2026, according to a timeline published by CMS on its Medicare Drug Price Negotiation Programopens in a new tab or window.

By no later than October 2, those same companies must submit "manufacturer-specific data" to CMS that the agency will factor into its consideration of what is a "maximum fair price." These data may include costs of research and development, production costs, and sales and revenue data.

This date is also the deadline for the public to submit data to the agency regarding therapeutic alternatives to the selected drugs, as well as data on "unmet medical need" and impact on specific populations, according to an agency fact sheet.

By Feb. 1, 2024, CMS will share its initial maximum fair price offers with a justification, and companies will have 30 days to accept or suggest a counter-offer.

The negotiation period is slated to end Aug. 1, 2024. By September 1, CMS will publish the maximum fair prices that the agency has negotiated for these 10 drugs, and the negotiated prices will take effect beginning Jan. 1, 2026.

Looking ahead, CMS will choose up to 15 additional drugs for price negotiation for 2027, up to 15 more drugs (to include drugs covered under Medicare Part B) for 2028, and up to 20 more drugs for price negotiation each year after that, as stated in the IRA.

In addition to allowing Medicare to negotiate drug prices, the IRA looks to lower healthcare costs in other ways, including capping annual out-of-pocket expenses for Medicare Part D drug plans at $2,000, requiring drugmakers to cough up federal rebates if they hike prices above inflation levels, and maintaining the enhanced tax credits for those with Affordable Care Act coverage.

Reactions and Expected Backlash

Nancy LeaMond, executive vice president and chief advocacy and engagement officer of the AARP (formerly known as the American Association of Retired Persons), praised the administration for taking action to "bring down out-of-control prescription drug prices."

"For too long, big drug companies have fleeced our country and padded their profits by setting outrageous prices, all at the expense of American lives," LeaMond said in a statement to press. "The number one reason seniors skip or ration their prescriptions is because they can't afford them. This must stop."

"We cannot overstate how monumental this law is for older Americans' financial stability and overall health," she added.

Pharmaceutical companies have already taken aim at the new law by launching a "blizzard of lawsuits"opens in a new tab or window to try and block it, including AstraZeneca, Astellas, Bristol Myers Squibb, Johnson & Johnson, and Merck, as well as the drug industry's trade group, the Pharmaceutical Research and Manufacturers of America.

"Today is a regrettable milestone in the implementation of the Inflation Reduction Act's price control provisions, which will result in harmful reductions in biomedical innovation while failing to address the root causes of high out-of-pocket costs," said John Stanford, executive director of Incubate, a group of venture capital firms, in an emailed statement.

"Government price setting throws a wrench in the successful market-based drug development ecosystem that patients count on to deliver life-saving therapies," he added. "The uncertainty created by price controls will force many early-stage life sciences investors to direct their funds elsewhere."

https://www.medpagetoday.com/washington-watch/washington-watch/106102

CDC: Deaths From Counterfeit Pills, Notably Fentanyl, Rising

 Fatal overdoses from counterfeit pharmaceuticals, particularly pills found to contain fentanyls, more than doubled in recent years, the CDC reported.

Among more than 100,000 recent overdose deaths in the U.S., the percentage caused by pills disguised as legitimate pharmaceutical products increased from 2.0% in the third quarter of 2019 to 4.7% in the last quarter of 2021.

The proportion of those deaths involving illicitly manufactured fentanyls jumped to 93.0% from 72.2%, while illicit benzodiazepines also rose to 5.3% from 1.4%. Fake fentanyl was the sole drug involved in 41.4% of counterfeit pill-related deaths, compared with 19.5% of overdose deaths without evidence of counterfeit pill use.

Western states drove the increase in deaths with evidence of counterfeit pill use, with a rise from 4.7% to 14.7% across the study period, whereas percentages remained below 4% elsewhere, reported Julie O'Donnell, PhD, of the CDC, and colleagues in Morbidity and Mortality Weekly Report

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"The proliferation of counterfeit pills, which are not manufactured by pharmaceutical companies, but are typically made to look like legitimate pharmaceutical pills (frequently oxycodone or alprazolam [Xanax]), is complicating the illicit drug market and potentially contributing to [overdose] deaths," O'Donnell and colleagues wrote.

And it may unintentionally expose new populations to highly potent drugs.

"Counterfeit pills often contain illicitly manufactured fentanyls (IMFs), illicit benzodiazepines (e.g., bromazolam, etizolam, and flualprazolam), or other illicit drugs, and can increase overdose risk because the pills might expose persons to drugs they did not intend to use," they added.

The findings come against a backdrop of an overall increase in drug overdose death ratesopens in a new tab or window involving fentanyl, methamphetamine, and cocaine from 2016 through 2021, as previously reported by the CDC without respect to counterfeit status.

Prevention and education efforts "that are tailored to persons most at risk, and include outreach to those who do not frequent traditional harm reduction services, might be most successful," they wrote.

Effective messaging by public health entities might include highlighting the dangers of pills obtained and taken without a prescription, as well as encouraging drug product testing, O'Donnell and colleagues added.

Data examined for the study came from jurisdictions participating in CDC's State Unintentional Drug Overdose Reporting System (SUDORS), which included 29 states and the District of Columbia from July 2019 to December 2021, with an additional five states reporting data during 2021. Jurisdictions entered information about unintentional and undetermined intent overdose deaths from death certificates, post-mortem toxicology reports, and medical examiner and coroner reports.

As for means of drug use, smoking was the most common non-ingestion route among deaths with evidence of counterfeit pill use (39.5%) and was highest in western jurisdictions (55.1%).

More than half of deaths with evidence of counterfeit pill use involved counterfeit oxycodone, either alone (55.2%) or with counterfeit alprazolam (3.9%), researchers reported.

Decedents with evidence of counterfeit pill use were younger than those without such evidence (57.1% vs 28.1% under age 35) and more were Hispanic or Latino (18.7% vs 9.4%, respectively). Additionally, a higher percentage of deaths with evidence of counterfeit pill use were in people with a history of prescription drug misuse compared with those without such evidence (27.0% vs 9.4%).

Deaths involving oxycodone and alprazolam combined involved people of the youngest average age (26 years).

"Counterfeit pills have been marketed toward younger persons, who might have more recently started using drugs and have lower tolerance," O'Donnell and colleagues wrote. "Younger persons might also exhibit more risk-taking behaviors than do older persons, and engage less with harm reduction services."

"The higher percentage of Hispanic decedents could reflect the younger age of this population and the demographics of western states where evidence of counterfeit pill use was more common; nonetheless, it might still have implications for access to and use of prevention messaging materials and harm reduction services," they added, such as tailoring these messages and services to address potential engagement, language, or other barriers.

Limitations of the study included that analyses might not be generalizable beyond jurisdictions that were included, and that documentation of counterfeit pill use is likely underestimated, the researchers noted.

Furthermore, the definition for evidence of counterfeit pill use included pills found or reported to be at the overdose scene, and some overdose deaths might be included as having evidence of such use even if the decedent did not use the pills.

Disclosures

The authors reported no conflicts of interest.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: opens in a new tab or windowO'Donnell J, et al "Drug overdose deaths with evidence of counterfeit pill use -- United States, July 2019–December 2021" Morb Mortal Wkly Rep 2023; DOI: 10.15585/mmwr.mm7235a3.

https://www.medpagetoday.com/publichealthpolicy/publichealth/106153

CDC Details 2021 Multidrug-Resistant TB Outbreak in Kansas

 An outbreak of multidrug-resistant tuberculosis (TB) developed in Kansas in November 2021, and included multiple children who were born in the U.S. and became infected in the state, CDC researchers reported.

The outbreak involved 13 people across four households in Kansas City and spanned 1 year. While a majority of the seven adults identified were born outside the U.S. in a country that had experienced a multidrug-resistant TB outbreak with the same genotype in 2007-2009, most of the six children were U.S.-born, noted Elizabeth Groenweghe, MPH, of the Unified Government Public Health Department in Kansas City, and colleagues in the Morbidity and Mortality Weekly Reportopens in a new tab or window.

"This outbreak is ... a cautionary tale, reminding other low TB incidence jurisdictions that sustained declines in TB incidence are not assured," they wrote. "Successful TB treatment and prevention requires ongoing identification and treatment of [latent TB infection] and a swift multifaceted public health response for each person newly diagnosed with TB."

Nine additional people in the four affected households were diagnosed with latent infections, and one child in a neighboring state with an epidemiologic connection to the Kansas outbreak was also identified in July 2022.

All of the active infection isolates were resistant to rifampin, isoniazid, pyrazinamide, and ethambutol -- all first-line treatments -- but susceptible to second-line therapeutics, Groenweghe and co-authors said.

The outbreak began when an infant was hospitalized with pulmonary and meningeal TB. DNA sequencing confirmed that the infective strain was resistant to all four of the first-line drugs. An investigation by the local health department found four latent infections and four more active infections in the same household (household A), including a severely ill adult with pulmonary cavitary disease, who had exhibited symptoms since June 2021.

In January 2022, another case emerged, this time in a young child living in a different household (household B) in the same apartment building. Members of the two families socialized together extensively, shared a car, and commuted together to the same workplace.

The child was hospitalized with pulmonary TB and lymphadenitis; isolates had the same drug resistance profile as those from household A. The child's mother, who was pregnant, was soon diagnosed with pulmonary multidrug-resistant TB. Investigators found four more people in household B with active infection, including a severely ill young adult with pulmonary cavitary lesions, who had been symptomatic since September 2021.

The investigation also identified two additional households (C and D) with connections to households A and B, although located in a different neighborhood. Household C had two latent cases and two active cases, including a teen who had spent time in both households A and B; the teen was diagnosed with pulmonary multidrug-resistant TB and extrapulmonary TB vasculitis. Household D had three adults with latent infections.

Public health officials then investigated other contacts, a school, and a workplace. Potential contacts underwent an interferon-gamma release assay blood test or tuberculin skin test 8 weeks after their most recent exposure to any of those with TB.

Investigators thought the outbreak was contained within these four households until July 2022, when a child in a neighboring state was diagnosed with multidrug-resistant TB (household E).

"Additional investigation confirmed that the young adult from household B was also known to household E and had spent time in the home of household E while infectious," Groenweghe and team wrote.

Clinicians constructed individual treatment regimens for each person. Most of the adults (median age 29 years) and an older teenager in household A received 26 weeks of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM). The pregnant woman was treated with bedaquiline, linezolid, moxifloxacin, and clofazimine. After her baby was born and she stopped breastfeeding, she was switched to the BPaLM regimen for 6 more months.

"The infant, young child, other children, and young teenager presented a unique treatment challenge because BPaLM has not been studied in children aged <15 years," the authors noted.

Three of these children, ages 9-13, received 26 weeks of bedaquiline, linezolid, moxifloxacin, and delamanid. Delamanid is a multidrug-resistant TB medication used in Europe. The FDA granted a compassionate use authorization for these cases.

The infant and young child received bedaquiline, cycloserine, levofloxacin, and linezolid.

Length of treatment was clinically determined and differed in each case, but by September 2023, 13 of the 14 patients had completed treatment.

"One adult who received a clinical diagnosis of extrapulmonary TB disease declined treatment despite extensive measures on the part of public health and clinicians. Local public health staff members continue to maintain careful communication and relationship with this person, should they desire treatment, or should their disease progress further and pose a health risk to the community," Groenweghe and co-authors wrote.

The nine patients diagnosed with latent TB infections were all treated with 6 months of daily moxifloxacin. All completed treatment and none developed disease or complications. Local public health officials will continue to monitor all of the patients every 6 months for at least 2 years. This includes chest x-rays, review of signs and symptoms, and a physical exam.

The CDC's National TB Molecular Surveillance Center performed whole-genome sequencing on isolates from nine of those with culture-confirmed active TB. Whole-genome single nucleotide polymorphism (SNP) analysis showed that these isolates were very similar, differing only by up to three SNPs. This finding supported the investigators' hypothesis that the outbreak was locally transmitted within the social setting of these families.

The whole-genome SNP analysis also genetically tied the isolates to outbreaks that had occurred in the Federated States of Micronesia during 2007-2009 and Guam during 2009-2016. Some of the adults in the outbreak lived in those regions during those times.

"Both sentinel events of TB disease in the infant and young child included a plausible source within the household (i.e., a non-U.S.-born adult with a lengthy illness course and infectious period)," Groenweghe and team wrote. "At least one of these adults was likely infected overseas years earlier and then experienced progression to active TB disease after moving to Kansas. Unfortunately, neither of the plausible source persons received a diagnosis for many months, leading to further transmission."

"This outbreak in an urban, at-risk community resulted in tremendous financial, staffing, and capacity strain on the local public health department, where capacity was already diminished after nearly 2 years of COVID-19 pandemic response; however, recent collaborations established during COVID-19 prevention activities led to many positive working relationships with community partners such as the schools and hospitals, which facilitated efficient coordination of the outbreak response," the authors noted.

Disclosures

Groenweghe had no financial disclosures. Co-authors disclosed relationships with the Pacific Islands Tuberculosis Controllers Association Conference, the Heartland National Tuberculosis Center, the American Academy of HIV Medicine, the Advisory Counsel for the Elimination of Tuberculosis, and the Kansas Department of Health and Environment.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: opens in a new tab or windowGroenweghe E, et al "Outbreak of multidrug-resistant tuberculosis -- Kansas, 2021-2022" MMWR 2023; DOI: 10.15585/mmwr.mm7235a4.

https://www.medpagetoday.com/infectiousdisease/tuberculosis/106166

Britain first to approve Roche's subcutaneous Tecentriq

 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has become the first regulator to approve Roche's subcutaneous (SC) formulation of cancer immunotherapy Tecentriq, which aims to make treatment easier for patients.

The approval covers all indications for the current intravenous (IV) version of Tecentriq across lung, bladder, breast, and liver cancers, and Roche confirmed this morning that the new version will be provided by the NHS in England.

"We couldn’t have achieved this without the collaboration and support of stakeholders across the cancer community and we remain committed to ensure this treatment is available in Scotland, Wales and Northern Ireland as quickly as possible," said Marius Scholtz, medical director of Roche Products Limited.

Dosing with the SC version takes around seven minutes, while the current IV form requires a 30- to 60-minute infusion, so transitioning to the new form should save time for patients and healthcare staff and conserve resources in healthcare systems, according to Roche.

The MHRA approval covers England, Scotland, and Wales, while at the moment registration in Northern Ireland comes under the remit of the EMA, which has yet to make a decision on the new product. SC Tecentriq is currently under review in the EU, as well as in the US and other countries worldwide.

Last year, Tecentriq became the first SC drug in the PD-1/PD-L1 inhibitor class to clear a multinational phase 3 trial, matching the original formulation in the head-to-head IMscin001 study that involved immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had previously been treated with platinum-based chemotherapy.

The results showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.

So far, approved PD-1/PD-L1 inhibitors headed by MSD's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Opdivo (nivolumab) are all given by IV – other than a product brought to market within China only – so have fought for market share based on their clinical indications.

Now, Roche can add ease of administration to the competitive profile of Tecentriq, and extend the commercial lifespan of the drug with further patent protection. The company said that, while the IMscin001 trial was conducted within hospital settings, SC Tecentriq may be suitable for out-of-hospital administration as well.

Its rivals are not sitting still, however, with MSD and BMS both working on SC versions of their drugs in late-stage trials and Pfizer testing an experimental SC antibody, called sasanlimab, in the phase 3 CREST trial in bladder cancer, with results due next year.

Roche's new drug has been developed using Halozyme's Enhanze drug delivery technology, which has already been deployed in the big pharma's Herceptin (trastuzumab), Rituxan (rituximab), and Phesgo (pertuzumab/trastuzumab) product lines and is being used to create a new version of multiple sclerosis therapy Ocrevus (ocrelizumab).

https://pharmaphorum.com/news/gb-first-approve-roches-subcutaneous-tecentriq

Novartis hits back at Entresto selection on Medicare list

 Novartis has responded to the inclusion of its heart failure blockbuster Entresto on the list of the first 10 drugs that will be subject to Medicare pricing negotiations, claiming that the move will result in "worse access for patients".

The inclusion of Entresto (valsartan/sacubitril) on the list was something of a surprise, as there was no indication it might be under consideration in the build-up to the list's publication yesterday, and Novartis currently isn't among those drugmakers that have filed legal challenges to the negotiation process.

In a statement, the Swiss group said that it believes the negotiation initiative included in the Inflation Reduction Act (IRA) is effectively price-setting by the federal government and unconstitutional, and will "limit the pharmaceutical industry's ability to discover and develop new life-saving and meaningful medicines for the people who need them most."

In particular, it said it will "disincentivise innovation and post-approval research, particularly for small molecule medicines including, among others, those that treat cancer, heart disease, and mental illness – diseases that affect millions of Americans."

According to Novartis, Entresto is the first and only angiotensin receptor-neprilysin inhibitor (ARNi) currently FDA-approved for use in the US for the treatment of heart failure and has no therapeutic alternative, with around 587,000 Medicare patients taking the drug every year.

The company pointed out that, since being approved in 2015 for heart failure with reduced ejection fraction (HFrEF), it has run additional studies to extend the uses of the drug in heart failure, as well as paediatric populations.

"Under the IRA, which discourages the research and development of additional indications for small molecule medicines by implementing price controls nine years after the first FDA approval, we may not have been able to invest in researching and developing Entresto in these additional indications, depriving patients of a meaningful treatment advance," it said.

Former FDA Commissioner Scott Gottlieb – who has been a vocal critic of the IRA's approach to drug negotiations – said he was surprised at the inclusion of Entresto, as well as some others on the list, including AstraZeneca's Farxiga (dapagliflozin), Amgen's Enbrel (etanercept), and Johnson & Johnson's Stelara (ustekinumab).

Calling the policy a "synthetic loss of exclusivity" on drugs, Gottlieb warned of unintended consequences, including a shift towards the development of biologics that now have longer patent terms, reduced incentives for generics drugmakers to challenge patents on small molecule drugs, and a shift of investment out of Medicare indications.

https://pharmaphorum.com/news/novartis-hits-back-entresto-selection-medicare-list

Genentech Alecensa: 'Unprecedented' Phase III Results in Early-Stage Lung Cancer

 

• ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer (NSCLC), building on its long-established benefit in the advanced setting
• About half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cure
• These data will be submitted to health authorities globally and presented at an upcoming medical meeting

https://www.biospace.com/article/releases/genentech-s-alecensa-delivers-unprecedented-phase-iii-results-for-people-with-alk-positive-early-stage-lung-cancer/

Alvotech Tries Again for FDA Interchangeable Designation for Humira Biosimilar

 Alvotech has resubmitted its Biologics License Application to the FDA seeking an interchangeability designation for AVT02, its high-concentration biosimilar formulation of AbbVie’s Humira (adalimumab), CEO Robert Wessman announced in an investor call Thursday.

Wessman did not disclose a target action date yet but said that Alvotech is working toward a “satisfactory inspection” of its manufacturing campus in Reykjavik, Iceland. If approved, the biotech company also expects AVT02 to be a “material contributor” to its business in 2024.

The FDA has already rejected AVT02 twice. The first was in April 2023, with the regulator citing deficiencies at the Iceland facility in its Complete Response Letter. The second rejection came in June, when the FDA turned down Alvotech’s bid for an interchangeability designation for AVT02.

In July, Alvotech broadened its collaboration with development partner Teva Pharmaceuticals, which involved the latter’s “increased involvement” in manufacturing and quality control at the Reykjavik plant.

Alvotech’s plant was slapped with a warning letter from the FDA in March 2022, which revealed several quality control issues. These included “an unacceptably high number of mold recoveries” from drug manufacturing rooms. The FDA also documented bacterial contamination exceeding acceptable levels.

In addition, the company’s corrective and preventive measures were deemed “inadequate” by the regulator as they did not ensure that future contaminations could be avoided.

“We have made and continue to make significant investments in our manufacturing and quality processes and have taken the feedback received from FDA inspections to focus these investments,” Wessman said during Thursday’s call. “We are confident that the changes that we have made at our site to put the company in the best positions for our satisfactory reinspection.”

If approved, AVT02 will face off with at least eight Humira biosimilars, a group led by Amgen’s Amjevita, which hit the U.S. market in January 2023. The floodgates opened in July, with several other biosimilars launching including Celltrion’s Yuflyma, Organon’s and Samsung Bioepis’ Hadlima, Sandoz’s Hyrimoz and Boehringer Ingelheim’s Cyltezo.

Of these, only Cyltezo has the interchangeability designation, which allows pharmacies to dispense it in place of its branded counterpart without needing a change in prescription.

Alvotech on Thursday also reported its financial results for the first half of 2023 posting $22.7 million in earnings, a substantial increase from its $3.9 million revenue over the same period last year.

https://www.biospace.com/article/alvotech-tries-again-for-interchangeability-designation-for-humira-biosimilar/