Market Access

MMIT Reality Check on Hemophilia A (Factor VIII) (Oct 2020)

October 16, 2020

According to our recent payer coverage analysis for hemophilia A (factor VIII) 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 (factor VIII) 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 (factor VIII) treatments shows that under the pharmacy benefit, about 42% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: The market is trending toward longer half-life recombinant products. Anticipated product approvals may develop improved product placement based on potential costs, adherence and efficacy advantages. The market will be managed more tightly as we start seeing an increase in longer acting products and gene therapy products in the pipeline.

Radar On Market Access: CVS, OptumRx Exclude Brand-Name Inhalers From 2021 Formularies, Switch Up Diabetes Supplies

October 13, 2020

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

CVS Health Corp.’s Caremark will exclude 57 medications from its 2021 formulary and add six back. Meanwhile, UnitedHealth Group’s OptumRx subsidiary will exclude 19 medications and products while adding back five and implementing restrictions on others, AIS Health reported.

Still, only a handful of products excluded by either PBM are likely to impact many members adversely, says Marc Guieb, a pharmacist and consultant with Milliman Inc. That also applies to the exclusions announced earlier by Cigna Corp.-owned PBM Express Scripts, he adds.

Guieb observes that brand-name albuterol inhalers are seeing exclusions in 2021 from multiple PBMs, and that’s the change that will affect the most members. “That’s a big one this year,” he says. “One of the PBMs’ new strategies is, they’re completely excluding all the brands of albuterol inhalers, and they’re just going with the generic.”

Meanwhile, “the change that will actually cause the most widespread disruption and confusion will be diabetics switching to entirely new blood glucose monitoring systems, which is a hassle,” Guieb says.

PBMs that decide to prefer one specialty drug over another also can cause significant member disruption, Guieb adds, pointing to potential issues involving Novartis Pharmaceuticals Corp.’s biologic Cosentyx (secukinumab), which was excluded from Express Scripts’ 2021 formulary in favor of Eli Lilly and Co.’s Taltz (ixekizumab).

Overall, “I will say that for a lot of these annual formulary changes, they’re definitely a step in the right direction, although it may not be a big enough step in the right direction,” Guieb adds.

For 2021, OptumRx is changing up its multiple sclerosis coverage, adding Biogen’s Tecfidera (dimethyl fumarate) to its excluded list and preferring bioequivalent Bafiertam, made by Banner Life Sciences. Biogen’s Vumerity (diroximel fumarate) remains excluded.

Brian Anderson, a principal at Milliman, tells AIS Health that the products added back by PBMs can be “just as interesting” as those excluded.

Caremark is adding back seven products, six of which are preferred. OptumRx is adding back the Accu-Chek glucose meters, along with Teva Pharmaceuticals USA Inc.’s ProAir inhalers, Anderson says.

Add-backs can confuse plan members, Anderson points out. “It’s really hard for a plan or employer to explain to their membership why a drug that was excluded last year is now covered again,” he says.

MMIT Reality Check on IBS-C (Oct 2020)

October 9, 2020

According to our recent payer coverage analysis for the treatment of irritable bowel syndrome with constipation (IBS-C), combined with news from key healthcare influencers, market access is shifting in this drug landscape.

According to our recent payer coverage analysis for the treatment of irritable bowel syndrome with constipation (IBS-C), 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 IBS-C treatments shows that under the pharmacy benefit, about 40% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In September 2020, the FDA authorized an investigational new drug (IND) application from Seed Health to evaluate the impact of its DS-01, a broad spectrum probiotic, on gut microbiota of patients with irritable bowel syndrome.

Trends That Matter on Trump Administration’s Rebate Order

October 8, 2020

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

A promised executive order that would tie drug prices to their costs in other countries has yet to emerge, although President Donald Trump has promoted the order as part of his re-election campaign. Meanwhile, payers and PBMs are continuing to push back against three executive orders the Trump administration issued in July with the intention of lowering drug prices, one of which would overhaul the Medicare Part D prescription drug rebate system, AIS Health reported.

“I think the purpose of these executive orders is to give the president some talking points going into the debates,” says Avalere Health founder Dan Mendelson. He adds that, regardless of their purpose, the orders will not make a difference in the real world any time soon.

Meanwhile, the executive orders that actually have been released are being criticized from stakeholders across health care. The order that would remove safe harbor protections from the Anti-Kickback Statute for prescription drug rebates in Medicare Part D has been panned even by conservatives.

Alex Brill, a resident fellow at the American Enterprise Institute (AEI), penned a white paper sponsored by PBM trade group Pharmaceutical Care Management Association (PCMA) that concluded the executive order would “restrict an important tool for providing savings to the federal government and Medicare Part D beneficiaries. Moreover, net drug costs and drug company revenues would rise significantly if the Medicare Part D safe harbor for rebates is eliminated.”

MMIT Reality Check on Merkel Cell Carcinoma (Oct 2020)

October 2, 2020

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

According to our recent payer coverage analysis for Merkel cell carcinoma 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 Merkel cell carcinoma treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In April 2020, the FDA approved the supplemental biologics license application (sBLA) for Merck & Co., Inc.’s Keytruda (pembrolizumab) to include an additional recommended dosage of 400 mg every six weeks across all adult indications. The new dosing option is in addition to the approved dosage of 200 mg every three weeks.

Radar On Market Access: New Manufacturing Approach May Drive Down CAR-T Therapies’ Prices

October 1, 2020

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

This summer, a drug called Tecartus (brexucabtagene autoleucel) became the third chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA. CAR-T therapies, which use a patient’s genetically modified immune cells to target and fight cancer cells, are a cutting-edge type of treatment that comes with eye-popping price tags, ranging from $373,000 to $475,000. However, a new report from OptumRx highlights an “industry trend to watch” that could eventually provide some relief to payers worried about how to finance CAR-T treatments, AIS Health reported.

Currently, CAR-T therapies’ high cost is at least in part attributable to the “labor-intensive and time-consuming” manufacturing process for such drugs, stated the UnitedHealth Group-owned PBM’s Drug Pipeline Insights Report for the third quarter of 2020. Essentially, T-cells are taken from a patient, treated and multiplied in a lab, and reinfused into the same patient — a completely personalized process known as autologous therapy.

As the industry searches for a cheaper and more scalable way of manufacturing CAR-T treatments, a new approach known as an allogeneic process “is currently under study as one possible solution,” according to OptumRx. In this process, previously extracted and banked healthy donor T-cells are multiplied “many times over for use in many patients,” effectively spreading out the high initial manufacturing cost over multiple doses.

When asked how much the allogeneic process could reduce the manufacturing cost of CAR-T therapies, Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, cited a 2019 study.

“Per the International Society for Cell and Gene Therapy, the cost to manufacture CAR-T using current methods is at $95,780 per dose,” he says via email. “That study also calculates the production cost using the new process would be only $4,460 per dose — over 95% lower.”

However, because manufacturing costs are only one part of the drug-pricing equation, the new allogeneic process may not actually lower CAR-T prices that dramatically, the report noted.

Tecartus’ list price is $373,000, and the wholesale acquisition costs of the other CAR-T therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), are $373,000 and $475,000 respectively, per the OptumRx report. As of Oct. 1, 2019, CMS agreed to cover CAR-T therapies for qualifying Medicare beneficiaries, but private payers generally reimburse providers for CAR-T treatment on a case-by-case basis, industry experts previously told AIS Health.