Speciality

Radar On Market Access: More Than 1,000 RM/AT Products Are in Pipeline

August 15, 2019

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

This past quarter saw two new gene therapies: Novartis AG subsidiary AveXis, Inc.’s Zolgensma (onasemnogene abeparvovec-xioi) received FDA approval May 24 for the treatment of spinal muscular atrophy, and bluebird bio’s Zynteglo (autologous CD34+ cells encoding βA-T87Q- globin gene) received conditional marketing authorization from the European Commission for transfusion-dependent beta thalassemia.

While only a handful of therapies in the broader regenerative medicine/advanced therapy (RM/AT) space are available globally, a new report shows that is likely to change, as there are more than 1,000 products in the pipeline, AIS Health reported.

The Alliance for Regenerative Medicine published the report, titled Quarterly Global Regenerative Medicine Sector Report: Q2 2019, on Aug. 1. It shows there are 1,069 clinical trials using specific RM/AT technologies, which include gene therapy, gene-modified cell therapy, cell therapy and tissue engineering. Ninety-four of those products are in Phase III trials.

While Zolgensma’s $2.125 million price for a one-time infusion makes it the costliest drug on the planet, many other newer RM/AT products are certainly not cheap. Though many manufacturers are offering various reimbursement schemes, including rebates if a therapy doesn’t work, other outcomes-based deals and multiyear pay-over-time payment options, experts note that many barriers exist in the execution of these strategies.

“In principle, spreading the cost over a five-year period and putting the cost installments at risk based upon efficacy is a good approach,” says Winston Wong, Pharm.D., president of W-Squared Group, about Zolgensma. “However, the devil is in the details. Do we have the systems in place that have the capability to administer a five-year contract?”

According to Wong, “From the manufacturer perspective, a value-based contract implies that no payment would be made if the patient relapses or passes on. Systems are not in place to have the ability to track the patient once therapy is administered.”

MMIT Reality Check on Ulcerative Colitis (Aug 2019)

August 9, 2019

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

According to our recent payer coverage analysis for ulcerative colitis 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 ulcerative colitis treatments shows that under the pharmacy benefit, about 62% and 58% of the lives under commercial and health exchange formularies are covered with utilization management restrictions, respectively.

Trends: In April 2019, Highmark Inc. said it is targeting autoimmune diseases under a new outcomes-based contract with Takeda Pharmaceuticals U.S.A., Inc. for Entyvio (vedolizumab).

MMIT Reality Check on Merkel Cell Carcinoma (Aug 2019)

August 2, 2019

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 27% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: In December 2018, the FDA gave accelerated approval to Keytruda (pembrolizumab) for use in adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

MMIT Reality Check on Parkinson’s Disease (Jul 2019)

July 26, 2019

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

According to our recent payer coverage analysis for Parkinson’s disease 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 Parkinson’s disease treatments shows that under the pharmacy benefit, about 45% of the lives under commercial formularies are covered without utilization management restrictions.

Trends: Given the number of generic orals, management of the remaining name-brand oral products is restrictive but less so than in other classes. With many strong orals available, understanding how restrictions translate (or don’t) to brand-name products is critical.

MMIT Reality Check on Kidney Cancer (Jul 2019)

July 19, 2019

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

According to our recent payer coverage analysis for kidney cancer 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 kidney cancer treatments shows that under the pharmacy benefit, about 58% of the lives under commercial formularies are covered with utilization management restrictions.

Trends: Currently, Sutent leads the renal cell carcinoma market and may have bolstered its standing with 2017’s label expansion to include use in the adjuvant setting.

Radar On Market Access: In Medicare Part D, Generic Drugs May Not Always Be Cheaper

July 16, 2019

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

A recently published study in Health Affairs shines a light on a peculiar quirk of the Medicare Part D benefit structure: For some high-priced specialty medications, seniors might pay less out-of-pocket for brand-name drugs than their generic counterparts.

The study found that, assuming a 61% discount between brand-name and generic drugs, Part D beneficiaries with prescriptions costing between $22,000 and $80,000 per year would have lower out-of-pocket spending if they use brand-name drugs over a generic, AIS Health reported.

“That’s really frustrating for consumers because you may actually not be in a plan that allows you to switch to a branded drug” if it’s cheaper than the generic, says Stacie Dusetzina, one of the study authors and an associate professor at Vanderbilt University.

“The other practical thing is, that would a terrible thing for us to be trying to get people to do because generally we want to encourage people to use generic drugs because they’re the best deal for us as a society,” she says.

Sharon Jhawar, chief pharmacy officer at California-based SCAN Health Plan, points out that because most generic prescriptions filled by seniors are not pricey specialty ones, “this kind of nuance that’s happening [with the Part D benefit] is kind of narrow and limited in scope.”

“But we know that the specialty pipeline is robust,” and so taking a look at the problem and figuring out solutions “does make sense,” she says.

However, well-intentioned policy changes don’t always turn out as planned, notes Kelly Brantley, a managing director at Avalere.

“Part D is so complicated, it’s hard to know what sort of fixes drive other quote-unquote problems,” she says.