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MMIT Reality Check on Hemophilia A or B With Inhibitors (July 2020)

July 3, 2020

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for hemophilia A or B with inhibitors treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for hemophilia A or B with inhibitors treatments shows that under the pharmacy benefit, about 48% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved Laboratoire Francais du Fractionnement et des Biotechnologies S.A.’s Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes in people at least 12 years old with hemophilia A or B with inhibitors.

Trends That Matter for DMD Therapies

July 2, 2020

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

Since 2016, the FDA has approved a handful of therapies to treat Duchenne muscular dystrophy (DMD). But some uncertainty exists over their effectiveness, in addition to concerns about their costs.

When DMD is suspected, a blood test that measures creatine kinase (CK) levels is performed. “CK is an enzyme found in abnormally high levels when muscle is damaged,” Mesfin Tegenu, R.Ph., president of PerformRx, LLC., tells AIS Health. “The detection of an elevated CK level leads to molecular genetic testing to confirm a definitive diagnosis of DMD.”

In February 2017, the FDA approved then-manufacturer Marathon Pharmaceuticals LLC’s Emflaza (deflazacort). The company said it would be priced at $89,000, which sparked outrage since people have been buying a generic version from overseas since the 1990s for about $1,000 per year. After the backlash, Marathon ultimately sold the drug to PTC Therapeutics Inc., which launched it later that year with a $35,000 annual price tag. Since then, PTC has raised the price to more than Marathon’s original one.

In September 2016, the FDA gave accelerated approval to Sarepta Therapeutics, Inc.’s Exondys 51 (eteplirsen). The dystrophin gene has 79 exons, and about 80% of people with DMD have genotypes that are amenable to exon skipping. Exondys 51 targets those with a mutation of the DMD gene that is amenable to exon 51 skipping.

Sarepta also has a second exon-skipping therapy, Vyondys 53 (golodirsen), which treats DMD in people with a mutation amenable to exon 53 skipping. The FDA gave the drug accelerated approval in December, almost four months after the agency rejected the drug through a complete response letter.

Both drugs are weight-based with similar prices: about $300,000 per year but up to $1 million annually.

“It’s unclear how much a health plan may spend on someone with DMD; however, a recent study from the Muscular Dystrophy Association found that the annual cost for DMD for U.S. society as a whole is around $362-$488 million dollars,” says Tegenu. “The price of the newer DMD therapies (Exondys 51 and Vyondys 53) are both estimated to cost approximately $750,000 per year for the treatment of one patient.”

Radar On Market Access: Insurers Are Required to Cover Only ‘Medically Necessary’ COVID-19 Tests

July 2, 2020

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

As more employers turn to COVID-19 testing to see if employees are safe to return to the workplace, the Trump administration has clarified that insurers must cover only physician-ordered “medically necessary” diagnostic and antibody tests, AIS Health reported.

The guidance, released jointly on June 23 by HHS, the Dept. of Labor and the Dept. of the Treasury, also says self-funded employer plans must pay for COVID-19 testing that’s medically appropriate.

“Testing conducted to screen for general workplace health and safety (such as employee ‘return to work’ programs), for public health surveillance for SARS-CoV-2, or for any other purpose not primarily intended for individualized diagnosis or treatment of COVID-19 or another health condition is beyond the scope” of the requirements embedded in the legislation approved by Congress earlier this year that requires insurers to pay for COVID-19 testing, the FAQ document said.

“I think now that [the insurers] have had this clarification, they’re going to use that as part of their determination of coverage,” Ashraf Shehata, KPMG national sector leader for health care and life sciences, tells AIS Health.

Richard Hughes IV, managing director at Avalere Health, says that it’s possible to argue that Congress intended insurers to cover all tests for their members, regardless of whether a physician ordered them, whether the person was symptomatic, or whether the test was needed to return to work.

However, Hughes says it’s also possible to argue that Congress gave CMS the authority to implement these testing requirements with some restrictions. “There could be tremendous variability across payers’ approaches to coverage policy and how they process claims,” he says.

In fact, many insurers already have moved to limit testing coverage in some ways, although their policies are fluid and have been updated frequently, says Danielle Showalter, principal at Avalere.

Individuals whose plans will not cover a test can turn to what Shehata calls the “retail model,” which is direct-to-consumer COVID-19 testing sites that don’t require a health care provider’s permission. Costs vary for this type of testing, which generally wouldn’t be covered by insurance unless the person is symptomatic.

Radar On Market Access: CMS Proposes New Medicaid Best Price Rules for Pricey Therapies

June 30, 2020

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

In an effort to boost adoption and lower costs for curative therapies, CMS proposed a new rule that the agency says would allow state Medicaid plans to enter into value-based, outcome-dependent purchasing agreements with drug manufacturers using a new interpretation of best price rules, AIS Health reported.

CMS proposed an updated interpretation of Medicaid “best price” rules by clarifying best price reporting requirements and enabling new structures including year-to-year scheduled prices that could change in relation to patient outcomes.

New curative therapies present a novel financial challenge for payers. Curative therapies eliminate the need for intensive treatment of chronic and terminal conditions, which create substantial savings for payers, patients and providers alike.

However, their high up-front cost is borne by payers and patients, and the initial payer may not see the entire financial benefit of the curative therapy. What’s more, under a traditional payment model, insurers are unable to recoup costs if a new, experimental therapy with curative potential has limited effect.

In order to spread risk and value across all stakeholders involved, some drug benefit industry leaders have called for broad adoption of the value-based pricing methods CMS’s proposed rule seeks to create, backed by a reinsurance mechanism.

Avalere Health principal Mike Schneider tells AIS Health that, although CMS’s proposal does not include a reinsurance mechanism, it should advance adoption of curative therapies. He says that, as they are currently implemented, Medicaid’s best price rules have made it difficult for commercial payers to negotiate with drug manufacturers to include outcomes and proof of concept in purchasing agreements.

Though the proposed rule applies directly to state Medicaid plans, Schneider says that the rule could have a substantial impact on the commercial market as plans bidding on Medicaid contracts gain experience with the new paradigm.

Still, barriers remain in adopting new curative therapies. Drug Channels Institute CEO Adam Fein points out that the rule does not address the challenge presented by copay accumulators to patients who might benefit from expensive, new specialty drugs — which suggests the rule might not speed up curative therapy adoption as quickly as patients might hope.

MMIT Reality Check on Ankylosing Spondylitis (June 2020)

June 26, 2020

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for ankylosing spondylitis treatments, combined with news from key healthcare influencers, market access is shifting in this drug landscape.

To help make sense of this new research, MMIT’s team of experts analyzes the data and summarizes the key findings for you. The following are brief highlights. To read the full piece, including payer coverage, drug competition and prescriber trends, click here.

Payer Coverage: A review of market access for ankylosing spondylitis treatments shows that under the pharmacy benefit, about 69% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The FDA’s recent approvals of two interleukin-17A (IL-17A) antagonists — Eli Lilly and Co.’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — to treat active non-radiographic axial spondyloarthritis, a less advanced form of ankylosing spondylitis, provide a new mechanism of action.