Specialty Pharmacy

Alnylam Launches New Gene Silencing Drug

August 21, 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.

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.

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.”

Cloud-Based Specialty Pharmacy Platform Provides More Flexibility

July 26, 2018

The combined central specialty and home delivery pharmacy formed by Walgreen Co., a division of Walgreens Boots Alliance, Inc. and Prime Therapeutics LLC known as AllianceRx Walgreens Prime, recently unveiled a five-year deal through which it is collaborating with health care technology company Inovalon Holdings, Inc. to roll out ScriptMed Cloud. The specialty pharmacy platform, says AllianceRx Walgreens Prime, will drive operational efficiencies and improve overall patient care.

AllianceRx Walgreens Prime and Inovalon have worked together to “customize the system [ScriptMed] to us,

The combined central specialty and home delivery pharmacy formed by Walgreen Co., a division of Walgreens Boots Alliance, Inc. and Prime Therapeutics LLC known as AllianceRx Walgreens Prime, recently unveiled a five-year deal through which it is collaborating with health care technology company Inovalon Holdings, Inc. to roll out ScriptMed Cloud. The specialty pharmacy platform, says AllianceRx Walgreens Prime, will drive operational efficiencies and improve overall patient care.

AllianceRx Walgreens Prime and Inovalon have worked together to “customize the system [ScriptMed] to us, our workflow and the way we do business,” including “functionality enhancements built around our specifications,” explains Joel Wright, CEO of AllianceRx Walgreens Prime.

“To maximize the benefit from specialty medications people are taking,” a comprehensive health care portrait is needed. But within the health care system today, says Wright, “most information comes directly from the patient or prescriber.” Today, “we get only what’s shared in the prescription transaction and through talking with the patient.…You almost have to extract that data,” and it may not be comprehensive. But ScriptMed Cloud will allow AllianceRx Walgreens Prime the ability to “access primary source data,” which will help plug those gaps. Combined with real-time data sharing, this “helps maintain optimal therapy for patients,” he says.

Patients also will be able to “get on therapy more quickly,” as the software helps reduce the time it takes to fill a prescription. In addition, pharmacists will be able to have better conversations with patients because they’ll have more information.

ScriptMed Cloud also provides simultaneous coordination among stakeholders within the health care system through electronic health records, health information exchanges, payer systems and provider sites.

Another “significant” aspect of ScriptMed Cloud is “our ability to modularize the system,” says Wright. This capability “will potentially help us meet payer needs better” by being able to provide more specific, customized information to payers.

Varied Multiple Myeloma Therapies Exist, More in Pipeline

July 23, 2018

Although multiple myeloma is a relatively rare cancer, numerous therapies to treat it are available. Because of these products’ efficacy, they have made the disease manageable — and, as a result, costly.

“The mainstays of treatment for multiple myeloma are considered specialty medications and therefore placed into a specialty tier,” says Raechele McMahan, vice president and general manager, enterprise specialty pharmacy at Prime Therapeutics. “The therapies are also subject to utilization management, which primarily consists of prior approval.”

Although multiple myeloma is a relatively rare cancer, numerous therapies to treat it are available. Because of these products’ efficacy, they have made the disease manageable — and, as a result, costly.

“The mainstays of treatment for multiple myeloma are considered specialty medications and therefore placed into a specialty tier,” says Raechele McMahan, vice president and general manager, enterprise specialty pharmacy at Prime Therapeutics. “The therapies are also subject to utilization management, which primarily consists of prior approval.”

Multiple factors come into consideration when choosing a treatment regimen, such as a patient’s treatment goals and the person’s age and insurance coverage. Whether a patient is a stem cell transplant candidate should also be taken into account.

“Combination therapy is the standard of care for treating multiple myeloma,” says McMahan. “Due to the use of triple combination therapy in multiple myeloma, the average annual cost of treatment or multiple myeloma can range from $100,000 to more than $250,000.”

Multiple myeloma has some common comorbidities that may complicate a person’s treatment. “Patients are typically at high risk for exhibiting C.R.A.B. symptoms: C = hypercalcemia; R = renal failure; A = anemia; B = bone lesions,” McMahan says. “Each of these symptoms, if present, can cause either treatment modifications and/or additional therapies to be included to ease patient symptoms….Many of these patients also have an increased risk of infection, which may require antibiotics for treatment and/or immunoglobulin therapy for prevention.”

There are more therapies in the pharma pipeline, although “the FDA is not currently reviewing any multiple myeloma agents,” according to McMahan. She adds that there has been excitement for CAR-T therapy use.

How Will the Biosimilars’ Change Impact Part D?

June 18, 2018

In just a little more than six months, biosimilars reimbursed in Medicare Part D will get a boost from legislation passed earlier this year. Plans and patients also stand to win, but manufacturers, not so much.

In Part D, beneficiaries consistently pay a 25% cost share until they hit the catastrophic phase, when their responsibility decreases to 5% of the drug. During the initial coverage period, plan sponsors are responsible for 75% of a drug’s cost;

In just a little more than six months, biosimilars reimbursed in Medicare Part D will get a boost from legislation passed earlier this year. Plans and patients also stand to win, but manufacturers, not so much.

In Part D, beneficiaries consistently pay a 25% cost share until they hit the catastrophic phase, when their responsibility decreases to 5% of the drug. During the initial coverage period, plan sponsors are responsible for 75% of a drug’s cost; during the “donut hole” coverage gap, brand-name drugs’ manufacturers must pay 50% of the drugs’ cost, while plan sponsors’ responsibility drops to 25%. Biosimilar manufacturers, by contrast, are excluded from having to provide this discount, leaving plan sponsors’ responsibility at 75%.

Yet as of 2019, biosimilars will be treated the same as brand-name drugs rather than as generics in the coverage gap. The legislation also closes the Part D coverage gap discount program in 2019 as opposed to 2020.

Reclassifying biosimilars could impact physician prescribing, contend consultant Jim Martin, Ph.D., and Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. “Equalization of patient out-of-pocket costs in the donut hole may also make it more likely that Prescription Drug Plans will favor biosimilars in their drug formularies,” they add.

It will be interesting to see how manufacturers with branded medications will respond to the changes and how plans respond to manufacturers’ moves, says Andrew Cournoyer, R.Ph., vice president, director, payer access solutions at Precision for Value. “Will [manufacturers] offer additional rebates to incentivize payers to continue covering” the branded products? “Will plans look at implementing preferred and not preferred specialty tiers?” he asks.