Pharma lobby group opposes senators’ proposal to lower drug prices

Representatives of PhRMA opposed a proposal from the Senate Finance Committee to lower prescription drug prices in a meeting with U.S. President Donald Trump on Wednesday, the pharmaceutical industry lobby group said on Thursday.

The proposal aims to lower drug prices by forcing pharmaceutical companies to pay rebates to Medicare if they raise prices above the rate of inflation.

PhRMA said the legislation was not the right approach to keep drug prices down and imposes harmful price controls in Medicare Part D that includes self-administered prescription drugs.

The proposal, unveiled by Senators Chuck Grassley and Ron Wyden on Tuesday, also suggests a cap on out-of-pocket costs for drugs covered under Medicare’s Part D and changes to the program’s Part B that covers physician-administered drugs.

“It replaces the successful, market-based structure of Medicare Part D with Medicaid-style price controls that result in money going to the Federal treasury instead of seniors,” PhRMA said in a statement.

https://www.reuters.com/article/us-usa-healthcare-drug-pricing/pharma-lobby-group-opposes-senators-proposal-to-lower-drug-prices-idUSKCN1UK2B1

5 ways the Senate’s drug-pricing bill would change provider pay

The Senate’s major proposal to cut drug prices is roiling Washington’s pharma lobbying world, but with the sectors of the U.S. healthcare system so deeply entwined, hospitals and doctors would see some financial changes too, as the package would save more than $100 billion over a decade.

Here are five ways the legislation from Senate Finance Chair Chuck Grassley (R-Iowa) and ranking member Ron Wyden (D-Ore.) bleeds into the provider world.

1. Pay caps for Medicare Part B providers. The bill is wading into territory where the Obama administration failed and the Trump administration hasn’t yet made progress. Starting in 2021, Medicare Part B’s 6% add-on fee for hospital outpatient departments, ambulatory surgical centers and physician offices would be capped at $1,000 per drug per day. Starting in 2029, this cap could start increasing at the rate of inflation.
2. A push for biosimilars. One provision would push for more prescriptions of biosimilars through an increased add-on fee within Part B. The five-year increase would raise the 6% administrative fee for hospital facilities and physician offices to 8% of the biosimilar drug’s average sales price.
3. “Site-neutral” for Part B administrative fees. Starting in 2021, the “grandfathered” off-campus hospital outpatient departments that since 2015 get higher payments for administering Part B drugs would lose their special status. Off-campus hospital facilities that are paid under the outpatient payment system at time of enactment would keep their current pay structure.
4. Hospital facilities may compete with physician offices on price. Patients have to pay 20% of their treatment under Medicare Part B, but currently HHS only has to post their estimated costs in hospital outpatient departments and ambulatory surgical centers. This bill would add estimates for physician offices to the list so patients can see if they may potentially save money at a different facility.
5. Physicians could get incentives to use real-time benefit tools in prescribing. Part D plan sponsors would have to adopt real-time benefit tools to give their enrollees real-time cost information about their prescription drugs. Under this provision, physicians could get an optional pay boost under the Merit-based Incentive Payment System to use this tool so their patients can view alternative drugs, the negotiated price, their own expenses and pharmacy options.

https://www.modernhealthcare.com/politics-policy/5-ways-senates-drug-pricing-bill-would-change-provider-pay

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Invitae to make certain genetic tests available free of charge

Genetic testing company Invitae has begun making its screening programs available at no charge for conditions including muscular dystrophy, prostate cancer, cardiomyopathy, arrhythmia and lysosomal storage disorders.

The company is also offering follow-up genetic counseling to help users understand their results as well as the testing of family members of patients with hereditary genetic variants or conditions.

The goal is to address the barriers that keep testing out of reach for patients with insufficient insurance coverage, specifically in areas where early testing may be underutilized in the course of diagnosis and treatment, as well as use in clinical development.

“Genetic testing can offer tremendous benefits to patients, clinicians and the broader medical community by expediting diagnosis, facilitating earlier interventions, accelerating clinical trial recruitment, and providing real-world data insights into many devastating diseases,” Invitae Chief Medical Officer Robert Nussbaum said in a statement.

The tests’ costs will be underwritten by sponsors within Invitae’s network, according to the company, which separately lists several biopharma firms as commercial partners, including those developing related products and genetic therapies such as Biogen, BioMarin, MyoKardia, Alnylam and others.

After patients enroll in a testing program through their doctor, sponsors will receive de-identified information and contact information for the clinician, Invitae said.

In early June, Invitae launched a new service model that allows consumers to initiate and order health screening tests and receive genetic guidance through a telemedicine service. After ordering the test, users are linked with a clinician to determine its medical appropriateness, the company said.

Its offerings include proactive testing for genetic risk factors of disease, screening for carriers of gene variations that can be passed on to children and diagnostic tests, including for eligibility for clinical trials, with prices between $250 and $350.

https://www.fiercebiotech.com/medtech/invitae-to-make-certain-genetic-tests-available-free-charge

Roche, like Bayer, was hit in Winnti cyberattack

It turns out that Bayer was not the only pharma company targeted by the Winnti cyberattack believed to have been instituted by hackers tied to the Chinese government. Roche also was a victim.

Roche today confirmed it was hit after being named in an ARD public radio report in Germany discussing the Winnti cyberattack, according to Reuters. The Swiss drugmaker said it had detected and deflected the attack but also acknowledged there have been others.

“Roche has been targeted by various attackers in the past, including the group known as Winnti. These attacks were detected and remediated,” a company spokesperson said today in an email. “Roche hasn’t lost any sensitive personal data of our employees, patients, customers or business partners.”

The company said it works with authorities in the U.S., Europe and Switzerland on cybersecurity threats and shares information with other companies in and out of pharma about “ongoing threats.”

Other companies named in the report included Marriott and Lion Air as well as chemical companies BASF and Shin-Etsu.

Bayer earlier this year also acknowledged it had been hit in the attack that was detected early last year. It said it found no evidence that sensitive data had been tapped. Experts believe the Winnti attack was launched by the Chinese.

While both companies indicated they weren’t seriously compromised by cyberattacks, at least one drugmaker has been. It was in 2017 that Merck & Co. had its API production and some R&D and other systems seriously interrupted by the NotPetya attack. The intrusion, which evidence suggested was launched by Russia, infiltrated Microsoft systems that had not installed a needed security patch.

That attack also interrupted production of Merck’s Gardasil, one of its best-selling products, forcing the company to borrow doses from the Centers for Disease Control and Prevention’s stockpile to meet demand. In all, the attack cost Merck about $1 billion in lost sales, time and expenses to fix the problem.

https://www.fiercepharma.com/manufacturing/roche-like-bayer-was-targeted-winnti-cyber-attack

Lantheus down 21% on Q2 miss and guidance cut

Lantheus Holdings (LNTH -20.5%) slumps on below-average volume following its Q2 report that disappointed investors. Highlights:

Revenues: $85.7M (+0.1%); net income: $6.4M (-34.2%); EPS: $0.16 (-36.0%). DEFINITY sales: $54.6M (+18.5%).

TechneLite sales negatively impacted by multiple molybdenum-99 supplier issues.

Non-GAAP net income: $10.9M (-6.4%); non-GAAP EPS: $0.27 (-10.0%).

Cash flow ops: $21.1M (+3.8%).

Q3 guidance: Revenues: $83M – 85M; non-GAAP EPS: $0.18 – 0.20.

2019 guidance: Revenues: $346M – 350M from $358M – 363M; non-GAAP EPS: $1.09 – 1.12 from $1.14 – 1.17.

https://seekingalpha.com/news/3481698-lantheus-21-percent-q2-miss-guidance-cut

Marinus leaves the way clear for Sage

In the wake of a clinical trial failure Marinus plays down oral ganaxolone, but investors are unimpressed.

Despite Marinus’s best efforts there is no disguising the disappointment at the performance of oral ganaxolone in the group’s postpartum depression study Magnolia. While the company attempted a quick pivot back to the project’s IV form, and touted additional future ganaxolone uses, its stock crashed 60% this morning.

Marinus’s investment case had centred on ganaxolone becoming an oral competitor to Sage Therapeutics’ now approved IV postpartum depression drug Zulresso. IV ganaxolone cuts little ice with investors, and failure of the oral form has handed an easy win to Sage, which in SAGE-217 has a promising oral project of its own.

SAGE-217 had already dealt Marinus a blow when it yielded a surprisingly strong result in its phase III Robin trial in postpartum depression (JP Morgan 2019 – development shortcuts pay off for Sage, January 8, 2019). This ratcheted up the pressure, and meant that only a knockout result with oral ganaxolone would do.

Back burner

As it is investors today pretty much wrote off the chances of oral ganaxolone, and Marinus quietly shifted its ambitions to develop a non-hospital postpartum depression drug to the back burner.

At issue is the two-part, placebo-controlled Magnolia study, which first treated 58 subjects with rising IV doses, and then recruited 33 who were given IV ganaxolone by six-hour infusion followed by 900mg of the oral form once daily. The trial’s key secondary efficacy endpoint was change in HAM-D17 scores at 28 days.

Today Marinus revealed that, though the comparison versus placebo yielded impressive differences at six and 24 hours, by day 28 any benefit had been wiped out. This came on top of December’s data from part one of Magnolia, which were largely viewed as inconclusive.

Accordingly, Marinus played up the potential of treating hospitalised patients, saying these amounted to 10-20% of the severe postpartum depression population. And it set its sights on competing against not SAGE-217 but Zulresso, stating that IV ganaxolone could have the benefit of a faster six-hour onset and a different safety profile.

It attempted to blame the efficacy failure on subjects’ non-compliance, arguing that in the per protocol population in part two of Magnolia there was a 2.6-point improvement in 28-day HAM-D17 versus placebo, within the US FDA’s definition of a 2.5-point benefit being clinically meaningful.

Changes in HAM-D17 score for Magnolia’s ITT population (left) and per protocol (right). Source: Marinus presentation.

However, Marinus admitted that oral data did not meet its expectations, and told an analyst call: “The path forward for ganaxolone in depressive disorders will likely be as a 48-hour infusion.”

One problem might be that the oral dose was too low, it suggested, claiming that higher doses might hold promise as an adjuvant for IV ganaxolone. Still, no further work on oral ganaxolone will now be done without a partner, which might also be interested in additional uses like treatment-resistant depression.

True, despite the strength of Sage’s data SAGE-217 is no dead-cert in postpartum depression. The risk of syncope or loss of consciousness weighs heavy on Sage’s chances, and Marinus was quick to highlight that neither IV nor oral ganaxolone threw up any of these adverse events in Magnolia.

But Marinus has cash in the bank to last for just over 12 months, it has no chief executive at present, and it can only offer the promise of a fuller update by the year end. This, combined with the Magnolia data, does not make for a great bargaining position.

MARINUS’S TRIALS OF GANAXOLONE IN POSTPARTUM DEPRESSION
Study	Dosing	Trial ID	Data
Magnolia part 1	IV (60-140µg/kg/hr)	NCT03228394	Described as promising, but insufficient power to show statistically significant benefit
Magnolia part 2	20mg/hr IV + 900mg daily oral	NCT03228394	Safe & well tolerated; no difference in HDM-D17 score vs placebo in ITT population
Amaryllis	675-1,125mg/day oral	NCT03460756	Open-label trial, said to supprt devlopment of 1,125mg/day oral dose
Source: company presentation & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/trial-results/marinus-leaves-way-clear-sage

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NextGen down 17% after FQ1 miss and guidance cut

NextGen Healthcare (NXGN -17%) slumps on double normal volume in early trade in reaction to disappointing fiscal Q1 results released after the close yesterday. Highlights:

Revenues: $131.9M (-1.0%); net income: $1.2M (-53.0%); EPS: $0.02 (-50.0%).

Non-GAAP net income: $10.5M (-14.6%); non-GAAP EPS: $0.16 (-15.8%).

Cash flow ops: $17.0M (+466.7%).

2019 guidance: Revenue: $536M – 550M from $543M – 559M; non-GAAP EPS: $0.82 – 0.90 from $0.86 – 0.94.

https://seekingalpha.com/news/3481691-nextgen-17-percent-fq1-miss-guidance-cut