U.S. to boost drug price negotiation in Medicare Advantage health plans

The Trump administration said on Tuesday it would give Medicare Advantage health plans for the elderly new tools to negotiate for lower prescription drug prices.

The Centers for Medicare and Medicaid Services (CMS) said Medicare Advantage plans will be allowed to require that patients first try certain lower-cost drugs before moving to a more expensive alternative if the first treatment is not effective.

Medicare Advantage plans are administered by private health insurers, such as Aetna Inc (AET.N) and Humana Inc (HUM.N), and cover medical benefits for some 20 million seniors.

Until now, such requirements could not be made on drugs covered by Medicare Part B, which are administered in a hospital or doctor’s office.

The changes also affect Medicare Part D drugs that patients get at the pharmacy. The Medicare Advantage plans would be allowed to require patients try alternatives covered within Part D before moving on to physician administered drugs, that are typically much more expensive.

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In 2017, Medicare Advantage plans spent $11.9 billion on Medicare Part B drugs. These types of changes in the private market have generally resulted in savings of about 15 percent to 20 percent, according to the Department of Health and Human Services.

More than half of the savings will be required to be passed on to patients, CMS said.

U.S. President Donald Trump has made lowering prescription drug costs for U.S. consumers a top priority. He announced a blueprint for lower healthcare costs in May and his administration has been announcing new initiatives this summer.

The changes announced on Tuesday can take effect as early as 2019.

Medicare Advantage plans that choose to implement the so-called step therapy will be required to disclose the change to patients. They would be allowed to switch to another Medicare Advantage plan or to fee-for-service by March 31.

https://reut.rs/2OT46bJ

Trump says will make announcement next week on reducing drug prices

U.S. President Donald Trump said on Tuesday that his administration would make an announcement next week on reducing drug prices, but he did not offer specifics.

Speaking at a dinner with business leaders at his New Jersey club, Trump said, “We are announcing something next week which is going to get them down really substantially.”

Trump has made lowering the cost of prescription drugs an issue for his administration.

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At the dinner, he thanked Pfizer Inc (PFE.N), the largest U.S. drugmaker, for announcing last month that it would not follow through on a planned increase in drug prices.

Trump had previously taken aim at the company and other U.S. drugmakers for raising prices on some drugs.

In May, Trump unveiled a “blueprint” to lower drug prices that appeared to largely spare drugmakers and instead took aim at “middlemen” such as health insurers and pharmacy benefits managers, which demand hefty rebates in exchange for broad access to patients.

https://reut.rs/2OlprcW

Heart Monitoring a Must for Breast Cancer Patients on Herceptin

The widely used chemotherapy drug trastuzumab (Herceptin) can be life-saving for women with HER2-positive breast cancer, a particularly aggressive form of the disease.

But new research now adds to mounting evidence that the treatment can take a toll on the heart, increasing the risk for heart failure.

The complication is uncommon, and in many cases, the benefits of the chemotherapy still outweigh the risks. But the study authors stressed that regular heart monitoring of these high-risk patients, including younger women, should be a priority during treatment.

“This is an important finding, as to the best of our knowledge this is the first study to calculate the rates of cardiotoxicity in younger women using insurance claim data,” said the study’s lead author, Mariana Henry. She’s a graduate student at the Yale School of Public Health.

The study used diagnoses and insurance billing codes for nearly 16,500 women with non-metastatic invasive breast cancer who were a median age of 56 years old, and were treated with chemotherapy within six months of diagnosis. Of these patients, 4,325 of the participants received Herceptin, or trastuzumab-based chemotherapy.

The researchers found that 4.2 percent of the study patients developed heart failure. But rates of the condition were higher among those treated with Herceptin: 8.3 percent of these patients developed heart failure compared with 2.7 percent of those who did not receive this type of chemotherapy.

And the risk of heart failure increased with age.

Taking other chemotherapy drugs, known as anthracyclines, could also increase the likelihood of heart problems, the investigators found.

“While we were unable to directly look at obesity, comorbidities such as diabetes, which tend to be associated with obesity, were associated with a higher risk of heart failure,” Henry noted.

The researchers concluded that breast cancer patients treated with Herceptin require regular heart monitoring. Heart disease is the second leading cause of death among breast cancer survivors mainly due to the toxic effects of some cancer treatments, the study authors pointed out.

According to Dr. William Hundley, a cardiology professor at Wake Forest Baptist Medical Center, in Winston-Salem, N.C., “There is a surveillance program with echocardiograms during receipt of trastuzumab for this very purpose.”

This usually involves undergoing an echocardiogram, a procedure that uses ultrasound waves to assess heart function, every three months during treatment, explained Hundley, who was not involved in the new study. He added that treatment discussions between breast cancer patients and their oncologist should cover both the risks and benefits of any appropriate therapies.

In their study, Henry and her colleagues also analyzed the rate of heart-monitoring adherence among the chemotherapy patients.

Only 46 percent of those treated with Herceptin or trastuzumab-based chemotherapy had their heart function assessed before starting chemotherapy and received the recommended heart monitoring during treatment, the findings showed.

It’s unclear why rates of heart monitoring were low among these patients. The study authors suggested that some doctors may view it as unnecessary, particularly for younger women with fewer underlying health issues or other heart-related risks.

The researchers pointed out that younger women with long life expectancies may receive more aggressive treatment, which could increase their need for more careful heart monitoring.

If heart changes are detected, patients can talk to their doctor and make informed decisions about their treatment. In some cases, heart medications can help improve heart health during treatment, according to the American Heart Association.

Hundley added that scientists are also actively investigating if lifestyle adjustments — such as diet and exercise — could also help reduce the risk for heart problems among high-risk chemotherapy patients.

The study was published Aug. 6 in a special Imaging in Cardio-oncology issue of JACC: Cardiovascular Imaging.

More information

The U.S. National Cancer Institute has more about heart health during cancer treatment.

SOURCES: Mariana L. Henry, B.S., Yale School of Public Health, New Haven, Conn.; William G. Hundley, M.D., Wake Forest Baptist Medical Center, Winston-Salem, N.C.; August 2018, JACC: Cardiovascular Imaging

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Frequency Therapeutics in Phase 1/2 Trial of 1st-in-Class Hearing Restoration Med

 Frequency Therapeutics today announced that the first patients have been treated in a Phase 1/2 clinical trial to evaluate FX-322, a first-in-class drug candidate for hearing restoration from the company’s Progenitor Cell Activation (PCA) regeneration platform. The randomized, double-blind, placebo-controlled trial will assess the safety of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history consistent with either noise exposure or sudden hearing loss.

“This trial marks the first time a PCA drug candidate with the potential to restore hearing has ever been tested in adult humans and gives hope to the 48 million people in the U.S. with stable sensorineural hearing loss,” said David Lucchino, President, Co-founder and CEO of Frequency. “By using a proprietary combination of small molecules intended to awaken dormant progenitor cells, we are creating an entirely new therapeutic modality with the potential to activate the body’s existing regenerative capacity and ultimately cure diseased tissue without the complexities of traditional cell or genetic therapy. We are thrilled to launch this important trial with the support of our investigators, multiple clinical sites in the U.S. and most importantly the patient volunteers.”

The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, multi-center study of FX-322, which will be administered in patients with stable sensorineural hearing loss. The trial is expected to enroll up to 24 patients at several leading otolaryngology clinics in the United States. Patients will receive either an injection of FX-322 or a placebo in one ear with an initial follow up visit after two weeks, and will continue to be monitored for the following three months.

“Hearing loss is a condition that has historically not received much attention despite the widespread nature of the issue, due in part to the difficulty of access to the inner ear environment,” said Dan Lee, M.D., Pediatric and Adult Otology and Neurotology, Massachusetts Eye and Ear Infirmary, Associate Professor of Otolaryngology, Harvard Medical School, and Chairman of Frequency’s Clinical Advisory Board. “The early work done by Frequency has shown real potential for FX-322 to have a significant impact in patients with noise induced hearing loss. While this is a safety study, it is an important first step to examining FX-322 in adult patients with sensorineural hearing loss.”

“This Phase 1/2 trial builds on the success of our first-in-human study completed last year, which showed FX-322 to be well-tolerated and validated the potential for cochlear penetration when delivered using a standard intratympanic injection in patients scheduled for cochlear implant surgery,” said Carl LeBel, Ph.D., Executive Vice President, Clinical Development of Frequency. “The clinical evaluation of FX-322 for hearing restoration is a priority for us based on the unmet medical need of millions of patients around the world who have lost varying degrees of hearing function from chronic noise exposure or sudden hearing loss, and we look forward to reporting the results from this study toward the end of 2018.”

Information on the Phase 1/2 clinical trial can be found at clinicaltrials.gov with the identification number: NCT03616223.

https://bit.ly/2niiRZf

Recent Drug Scandals in China Spotlight Potential Global Supply Chain Issues

China is the largest supplier of active pharmaceutical ingredients (API) in the world, supplying 40 percent of APIs to global pharma companies. These are the parts of drugs that produce clinical effects. And a recent series of scandals and issues related to drug manufacturing in China has highlighted how many problems this could cause the global drug supply chain.

Chinese biopharmaceutical company Changsheng Bio-Technology is under investigation by Chinese regulators for allegedly falsifying data for a number of products. In November 2017, Chinese authorities indicated that two batches of DPT vaccines (diphtheria, whooping cough and tetanus) made by Changsheng and the Wuhan Institute of Biological Products didn’t meet national standards. On July 15, 2018, an unannounced inspection found evidence of forged data related to the company’s manufacture of approximately 113,000 rabies vaccines. At that time the State Drug Administration revoked the company’s license to produce the vaccine and initiated recalls. Production of the vaccine was suspended the next day, and on July 18, the Jilin Food and Drug Administration fined the company 3.4 million yuan ($502,000 U.S.) over the DPT vaccines from the previous year.

On July 20, the Jilin FDA indicated that the Shandong Disease Prevention and Control Centrehad about 252,600 substandard DPT vaccines made by the company. Two days later, the People’s Daily, what is described as the “Communist Party mouthpiece” published commentary on the scandal, calling for a thorough investigation. At this time, Chinese Premier Li Keqiangordered an immediate investigation. This was followed a day later—July 23, 2018—by Chinese President Xi Jinping calling the scandal “appalling” and ordering an investigation.

These are the latest and most dramatic, but recently the European Medicines Agency (EMA)and the U.S. Food and Drug Administration (FDA) published alerts over cancer-causing ingredients being used in a blood pressure drug supplied by Chinese company Zhejiang Huahai, resulting in a recall.

CNBC notes that about 80 percent of APIs used in the U.S. come from China and India.

“Many [Chinese] API companies do not strictly follow established [manufacturing] processes, and do not strictly record data,” John Lin, a partner at EY in China, told CNBC. “Regulatory authorities do not conduct enough spot checks on API producers due to insufficient staff.”

CNBC writes, “Domestic regulators are not required to inspect companies that produce solely for export. Companies importing Chinese APIs are expected to carry out their own tests and report irregularities to regulators such as the FDA and the EMA, who can inspect Chinese producers in China and impose import bans.”

CNBC notes that FDA warnings to Chinese pharma manufacturers have increased from five in 2014 to 22 in 2017. It also reports that Chinese manufacturers fear these warnings and that Peter Baker, a director in the U.S. FDA’s Beijing office, is dubbed “the killer” by people in the industry. Whether that’s just because he’s tough or because China has a history of executingexecutives for corruption isn’t clear.

Some of the issue appears related to lack of external resources. The U.S. FDA and the EMA have offices overseas that conduct inspections of manufacturing facilities that produce APIs and drugs that are exported. However, the FDA had only 17 staffers in China in 2016, which has 700 facilities that supply to the U.S. Raps, an industry organization focused on healthcare regulation wrote in a report in 2016 that, “Concerns over how FDA can adequately track the drug and API supply chain is starting to worry Congress.”

The FDA has since expanded its China presence to 22 staff members, which isn’t particularly encouraging, given China is a country with a population of about 1.4 billion people that exports $29 billion in APIs in 2017. The EMA says it conducts about 20 to 40 inspections of Chinese API manufactures every year. About 10 percent of those find non-compliance.

The China Food and Drug Administration is trying to toughen standards, and in 2015 introduced a regulatory framework similar to those seen in other countries.

Chen Xi, a professor at the Yale School of Public Health told CNBC that recent scandals “can be a major setback for China’s pharma industry. On the other hand, this scandal can be a good chance if the Chinese government takes this crisis as an opportunity to reform.”

https://bit.ly/2M3vMgi

Humana sues dozens of generic drug manufacturers for price-fixing scheme

Humana has filed a lawsuit against more than two dozen pharmaceutical companies for conspiring to fix the prices of widely used generic drugs, a scheme that forced the insurer to pay for drugs at artificially inflated prices.

The complaint, filed in the U.S. District Court for the Eastern District of Pennsylvania on Friday, adds to numerous ongoing investigations by the Department of Justice and nearly every state in the country. Humana said its allegations are “based on personal knowledge” of the price-fixing scheme as well as information made public during the state and federal investigations.

Communications between the drug manufacturers reveal that the companies schemed to obstruct competition and set, increase, or maintain the drugs’ prices, according to the 273-page complaint (PDF). It also alleges that the defendants made arrangements not to compete against each other.

The communications allegedly took place at trade association meetings and conferences, at dinners and other private outings, and via phone and text message. The lawsuit names nearly 30 manufacturers including Mylan, Novartis and Teva, nearly all of which have been subpoenaed by federal prosecutors. Heritage Pharma’s former CEO and president already cut a deal with state prosecutors last year and agreed to assist with the investigation.

Humana said it wants to “recover damages it incurred from egregious overcharges it paid for certain widely-used generic drugs, arising from a far-reaching conspiracy among Defendants and others to blatantly fix the price of such drugs.” The insurer has requested a jury trial and is seeking treble damages under the Clayton Antitrust Act.

Humana’s complaint includes a list of 16 specific generic drugs it purchased in “substantial quantities” for “grossly inflated prices” due to the conspiracy. Five of the drugs are used to treat cardiac conditions, including hypertension and high cholesterol; however, taken together, the 16 drugs treat a wide range of medical issues, from depression to arthritis to multiple sclerosis.

“For most patients prescribed one of the Subject Drugs, the drug is a necessity that must be purchased regardless of price,” Humana said.

Humana claims it spent more than $1.7 billion on the drugs listed in the complaint.

The insurer said there are also “various other persons, firms, entities, and corporations” presently unknown to the company that acted as willing co-conspirators in the scheme.

While Humana points out that the use of generic drugs saved the U.S. healthcare system $1.68 trillion between 2005 and 2014, the defendants’ collusion forced Humana to pay “artificially inflated prices at supracompetitive rates.” According to federal data, the prices of these drugs shot up as much as 8,000% over the course of years, months, or even weeks.

In November, 47 attorneys general representing 45 states, the District of Columbia, and Puerto Rico, and the Department of Justice filed suit against 18 pharmaceutical companies and two of those companies’ chief executives for conspiring to fix generic drug prices as well. Humana references the suit extensively in its own complaint.

One particular line of Humana’s complaint strikes at the heart of the drug pricing debate that has raged for decades.

“The United States is a venue ripe for illegal anticompetitive exploitation of prescription drug prices due to laws that regulate how prescription drugs are prescribed and how the prescriptions can be filled,” it said.

https://bit.ly/2vLhPsw

Wisdom tooth surgery increases risk for long-term use of opioids

Getting wisdom teeth pulled often comes with a side of potent painkillers to help the discomfort.

And a new research report published in the Journal of the American Medical Association on Tuesday warns those opioid drug prescriptions associated with the common dental procedure may be leading to long-term use among young people.

Researchers from the University of Michigan’s Institute for Healthcare Policy and Innovation examined the national Truven MarketScan, a national employer insurance database, to focus on 56,686 wisdom tooth patients between 2009 and 2015.

Among young people ages 13 to 30, the study found those patients who filled their opioid prescription either immediately before or after having their wisdom teeth pulled were 2.7 times more likely than their peers to still be filling opioid prescriptions weeks or months later.

Teens and young adults who had a history of mental health concerns, such as depression, or chronic pain conditions were more at risk to go on to persistent use.

“Until now, we haven’t had data on the long-term risks of opioid use after wisdom tooth extraction,” said Calista Harbaugh, M.D., a U-M research fellow with the Michigan Opioid Prescribing and Engagement Network, or Michigan OPEN. “We now see that a sizable number go on to fill opioid prescriptions long after we would expect they would need for recovery and the main predictor of persistent use is whether or not they fill that initial prescription.” In all, about 1.3% who filled an opioid prescription went on to persistent opioid use, defined as two or more prescriptions. In comparison, less than a percent of the 14,256 wisdom tooth patients who didn’t fill a prescription went on to persistent opioid use.

The numbers may sound small, but is a much larger figure than it sounds because of how common wisdom tooth surgery is, Harbaugh said.

The study comes in the midst of an opioid crisis, with opioid overdoses accounting for more than 42,000 deaths in the U.S. in 2016, more than any previous year on record. The Department of Health and Human Services estimates 40% of opioid overdose deaths involved a prescription opioid.

In the report, the authors recommend dentists and oral surgeons stop routinely prescribing opioids, instead opting for non-opioid painkillers for their wisdom tooth patients. If pain is acute, they suggest prescribing less than the seven-day opioid supply which was recommended in March by the American Dental Association. That recommendation came around the same time the Centers for Disease Control and Prevention suggested primary care providers avoid prescribing opioids when appropriate.

Moving forward, the Michigan OPEN team said they are studying wisdom teeth patients further by reaching out to patients and their parents about their experience and how many opioid pills they actually took to create evidence-based prescribing guidelines.

The group has previously released prescribing guidelines for other surgeries including mastectomies and appendectomies. Other health systems, such as Johns Hopkins and Dartmouth-Hitchcock have also begun creating surgery specific prescribing guidelines for opioids.

https://bit.ly/2AWqiie