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Radar On Market Access: Health Plans Are Hesitant to Add New Narcolepsy Drugs to Formularies

September 24, 2019

Two newly approved narcolepsy medications offer novel, possibly more effective options to people for whom older medications aren’t working well, but most health plans are requiring patients and providers to try generic alternatives first, AIS Health reported.

Two newly approved narcolepsy medications offer novel, possibly more effective options to people for whom older medications aren’t working well, but most health plans are requiring patients and providers to try generic alternatives first, AIS Health reported.

The FDA approved Jazz Pharmaceuticals’ Sunosi (solriamfetol) for adults with narcolepsy or obstructive sleep apnea in March and Harmony Biosciences, LLC’s Wakix (pitolisant) in August. Sunosi was launched in July, and Wakix is expected to be launched later this year.

Some researchers say Sunosi and Wakix may have advantages over older treatments. Still, plans have been reluctant so far to add Sunosi to their preferred drug lists, and they seem likely to take the same cautious approach with Wakix.

First-line treatment for narcolepsy generally involves stimulant medications such as methylphenidate, amphetamines or modafinil/armodafinil, says Mesfin Tegenu, R.Ph., president of PerformRx. “Efficacy of the agents rarely exceeds around 70% to 80% of the normal ability to stay awake,” Tegenu tells AIS Health.

Some stimulants, including modafinil and some forms of methylphenidates and amphetamines, are available in generic form, Tegenu says. “Many plans may require trial(s) of an available generic product prior to payment of a brand-only formulation, or trial of less costly alternatives to higher-priced generic items if there’s a significant price difference,” he says.

It’s not clear whether either Sunosi or Wakix provide substantially better outcomes than the therapies currently in use, says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy at Prime Therapeutics LLC.

Tegenu says that both Sunosi and Wakix are non-formulary products for now for PerformRx, since it’s not possible to know whether they’re equally or more effective than older treatments. They will be “handled the same as all newly available drugs: considered non-formulary until enough clinical data is made available to add them to the covered medications class of drugs.”

Radar On Market Access: AML Therapy Class Has Seen Boom Over Past Couple of Years

September 19, 2019

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup, AIS Health reported.

“Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed,” said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.

Many of the newer drugs are oral formulations, which, “in general, are easier to administer,” points out Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “Rather than having to go into a hospital or clinic for treatment, a patient can simply take a medication orally for their condition.”

Payers utilize a variety of management tactics with AML therapies. “Payers often require prior authorization of these therapies due to safety, concern for off-label usage and cost,” says Tegenu. A variety of drugs are used off-label for certain patient populations, he notes.

Asked if AML is a condition suited for value-based contracting, Tegenu asserts that “all therapies associated with high cost should have some kind of value-based payment models to make drug manufacturers an integral part of the health care delivery system. We plan to initiate this discussion with all leading pharmaceutical companies.”

According to Winston Wong, Pharm.D., president of W-Squared Group., the newer drugs would be better candidates for such deals due to AML’s heterogenicity and the fact that “the treatment foundation is still conventional chemotherapy, which for the most part is available as a generic.”

Perspectives on Million-Dollar Treatments

September 19, 2019

For large, self-insured U.S. employers, their No. 1 concern related to pharmacy benefits is how to finance treatments that come with seven-figure price tags.

For large, self-insured U.S. employers, their No. 1 concern related to pharmacy benefits is how to finance treatments that come with seven-figure price tags.

That’s one finding of the National Business Group on Health (NBGH) 2020 Large Employers’ Health Care Strategy and Plan Design Survey, AIS Health reported. Among the 147 employer respondents, 86% said they were either concerned or very concerned about “the impact of million-dollar treatments getting approved by the FDA.”

Ellen Kelsay, NBGH’s chief strategy officer, said at a press briefing in Washington, D.C., “the pipeline is looming — there are an estimated 14 new therapies in excess of $1 million each that are on the docket for FDA approval in the coming months and years.”

Nearly a quarter of large employers polled said that as of 2019, they are delaying the inclusion of newly launched treatments from their formulary to enable their PBM or health plan to better determine the treatment’s efficacy and safety, the NBGH survey noted.

Kelsay also highlighted the fact that 46% of employer respondents in the 2020 survey indicated they would consider a role for government in helping to negotiate prices for high-cost therapies.

“I think that’s a reflection of the frustration employers have” with how to finance high-cost treatments, NBGH President and CEO Brian Marcotte said at the briefing. “It’s not a question of are these good therapies. It’s a question of what can society afford — not just what can employers afford.”

When it comes to specialty drug management, the most notable area of growth is in the use of prior authorization (PA) for medications billed under the medical benefit. The share of employers using PA for drugs under the medical benefit rose from 36% in 2019 to 59% in 2020.

Radar On Market Access: New Solutions to Finance High-Cost Treatments May Raise New Questions

September 17, 2019

With concerns mounting about how health plan sponsors will pay for breakthrough treatments with ultra-high price tags, some major insurers are offering up new solutions aimed at easing that burden, AIS Health reported.

With concerns mounting about how health plan sponsors will pay for breakthrough treatments with ultra-high price tags, some major insurers are offering up new solutions aimed at easing that burden, AIS Health reported.

Cigna Corp. “appears at the forefront” of initiatives to cope with super-high-cost drugs, as Citi analyst Ralph Giacobbe puts it, given that the firm recently introduced a new solution that would help clients pay for and manage two gene therapies: Luxturna and Zolgensma.

Members whose plan sponsors pay a per-member per-month fee for Cigna’s new solution — called Embarc Benefit Protection — will pay nothing out of pocket for Zolgensma or Luxturna if they meet the clinical qualifications to be treated with one of those therapies.

“Employers are looking for solutions like that from their health plan partners and the PBMs,” says Steve Wojcik, vice president of public policy for the National Business Group on Health. However, while offerings like Cigna’s could help employers “smooth out the spikes in expenses,” businesses remain concerned about the overall costs of breakthrough therapies in the pipeline, he notes.

Besides Cigna, other major names in the insurance sector, such as CVS Health Corp.’s Aetna and Anthem, Inc., are working on their own solutions to help cope with high-cost therapies, including annuity-style payment arrangements and value-based contracts.

David Dross, managed pharmacy practice leader at the consulting firm Mercer, says some large, self-insured employers that are concerned about ultra-costly treatments are rethinking their decision to forgo stop-loss coverage.

However, issues can arise if clinical and financial management of a high-cost drug are done separately, he adds. In other words, a plan sponsor may determine that a member qualifies for a high-cost drug, but the stop-loss carrier that’s taking on the financial responsibility may not agree.

Radar On Market Access: Novartis’ Zolgensma Crisis May Not Impact Pickup

September 12, 2019

The FDA in August put out a statement addressing “data accuracy issues” with Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy to treat spinal muscular atrophy in people less than two years old who have bi-allelic mutations in the survival motor neuron 1 gene, AIS Health reported.

The FDA in August put out a statement addressing “data accuracy issues” with Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy to treat spinal muscular atrophy in people less than two years old who have bi-allelic mutations in the survival motor neuron 1 gene, AIS Health reported.

The FDA approved the drug from AveXis, Inc., which was acquired by Novartis AG last year, on May 24. On June 28, AveXis notified the FDA that there was “a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA.”

The FDA said Novartis learned about the issue March 14, but rather than informing the agency, which was assessing Zolgensma’s BLA at the time, the company conducted its own internal investigation, reporting its findings to the FDA after the investigation was completed. Still, the agency said that it “remains confident that Zolgensma should remain on the market.”

The one-time therapy is the most expensive drug in the world, with a price tag of $2.1 million.

In response, Novartis issued a press release Aug. 6 that read, in part, “we maintain that the totality of the evidence demonstrating the product’s effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile.”

Novartis recently said that Zolgensma has coverage plans from payers representing 40% of commercial lives, and high-profile news reports name Aetna Inc. and Anthem, Inc. among insurers expanding their policies to cover more patients. So will the current situation have any impact on pickup among payers and providers?

Based on the FDA’s statement, “I expect there will be no more than a minor and temporary blip in pickup of Zolgensma among providers and payers,” says Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates.

Radar On Market Access: Insurers Welcome Changes to Addiction Treatment Privacy Rules

September 10, 2019

A recent federal proposal — which would loosen privacy rules surrounding substance use disorder (SUD) treatment — is being applauded by health insurer trade groups. But some advocates are worried about potential harms to patients, AIS Health reported.

A recent federal proposal — which would loosen privacy rules surrounding substance use disorder (SUD) treatment — is being applauded by health insurer trade groups. But some advocates are worried about potential harms to patients, AIS Health reported.

At the center of the debate is legislation enacted in the 1970s and the subsequent regulations implementing that law, known as 42 CFR Part 2, which was designed to protect the confidentiality of SUD patient records created by federally funded treatment programs. Under the proposed changes to 42 CFR Part 2, opioid treatment programs would be able to enroll in state prescription drug monitoring programs and submit the dispensing data for controlled substances consistent with applicable state laws. SUD patients also would be able to consent to disclosure of their Part 2 treatment records to an entity, without having to name a specific person.

“At the highest level, ACHP does see the proposed rule as a positive development,” says Connie Hwang, M.D., chief medical officer of the Alliance of Community Health Plans. When an individual is undergoing treatment for SUD, “you want to make sure that all the other groups engaged in the ongoing care are aware and don’t inadvertently interfere with that or put the patient at greater danger,” she adds.

However, not everyone shares that view.

“While the Legal Action Center strongly supports the need for coordinated flow of health information between providers, it must be done so with patient consent in disclosure and re-disclosure,” Paul Samuels, president and director of the advocacy group, said in a news release.

The current privacy rules are “a necessary protection for individuals who would otherwise be susceptible to a multitude of detrimental consequences if their SUD information was disclosed without their permission to potential employers, housing providers, law enforcement and more,” Samuels added.