Product Release

Radar On Market Access: Alnylam Launches New Gene Silencing Drug

August 23, 2018

A new first-of-its-kind therapy is launching onto the U.S. marketplace with a costly price tag — and value-based deals with a handful of health insurers that should help with patient access while assuring them that they are paying for value, AIS Health reported.

On Aug. 10, the FDA approved Alnylam Pharmaceuticals, Inc.’s Onpattro (patisiran) for the treatment of adults with polyneuropathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis. It is the first drug the agency has approved for this condition,

A new first-of-its-kind therapy is launching onto the U.S. marketplace with a costly price tag — and value-based deals with a handful of health insurers that should help with patient access while assuring them that they are paying for value, AIS Health reported.

On Aug. 10, the FDA approved Alnylam Pharmaceuticals, Inc.’s Onpattro (patisiran) for the treatment of adults with polyneuropathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis. It is the first drug the agency has approved for this condition, as well as the first in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

Dosing for Onpattro, an intravenous infusion administered over about 80 minutes, is weight-based. With a cost per vial of $9,500, the average annual list price is $450,000, based on an average of 2.7 vials administered an average of 17.5 times per year. But after taking into account mandatory government discounts, Alnylam estimates that the average annual net price will be $345,000.

On Aug. 13, Orsini Healthcare Specialty Pharmacy and US Bioservices, a specialty pharmacy that’s part of AmerisourceBergen Corp., said that Alnylam had selected them to distribute Onpattro.

Barry Greene, Alnylam president, says that the company has been “negotiating value-based agreements with several insurers to ensure that payment for the drug is based on the ability of Onpattro to potentially halt or in some patients reverse neuropathy impairment.” Alnylam has “agreed in principle” with Harvard Pilgrim Health Care, Inc. “and other major insurance carriers” on the structure of such arrangements.

Besides Harvard Pilgrim, Aetna Inc. would appear to be another company inking a value-based deal for Onpattro, as Jim Clement, executive director of value based care and supply chain management at Aetna Pharmacy Management, said he was “looking forward to being a part of this Alnylam initiative.”

Radar On Market Access: Drug-Diagnostic Co-Development

August 7, 2018

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostic but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach, AIS Health reported.

Previously some companies would develop both the drug and the diagnostic,

As knowledge around biomarkers grows, more drugs are coming onto the market with FDA-approved labels indicating their use with a particular diagnostic test. With most manufacturers nowadays choosing not to develop their own companion diagnostic but rather to partner with an outside firm, pharma companies need to be able to incorporate a diagnostic strategy into their drug development approach, AIS Health reported.

Previously some companies would develop both the drug and the diagnostic, but the number that now do so has declined. According to Amit Agarwal at Deloitte Consulting LLP, “diagnostic is a very different margin and business model than the pharmaceutical industry….The economics of it differ pretty dramatically.”

It is most beneficial for pharma companies to partner with companies skilled in developing research assays and companion diagnostic tests, according to Karen Richards at Precision for Medicine.

When drugmakers are selecting a company to partner with, there are various considerations that go into the decision. “The strength of the technology they have or are developing is most important,” asserts Mark Ginestro, principal at KPMG Strategy. “Beyond that, partnerships need to consider strengths beyond technology, such as marketing, manufacturing, informatics, finances, relevant product development history and overall ability/willingness to make a deal.”

Because drug and diagnostic companies have different models and priorities, they need to make sure these are aligned within a co-development partnership. Pharma companies also need to make sure they keep their diagnostic partners “apprised of the time and investment needed by the drugmaker to move products through various trial phases,” say Richards and David Parker at Precision for Medicine.

Once the products are commercially available, the companies need to make sure their business interests remain aligned. With the shift from co-developing to co-marketing, “there are typically different parameters and success criteria governing the partnership,” Ginestro notes.