Specialty Pharmacy

Industry Insiders Have Conflicting Opinions on Proposed Drug Price Ad Rules

October 22, 2018

by Angela Maas

While HHS has taken multiple steps toward lowering prescription drug prices, the agency’s latest proposal has been its most contentious so far. And while it may succeed in providing consumers more information on drugs’ wholesale acquisition costs (WACs), industry experts wonder how effective it really will be in letting consumers know what they will pay for a drug.

The proposed rule would require direct-to-consumer (DTC) television ads for prescription drugs covered by Medicare or Medicaid that have a WAC of more than $35 per month to include that list price in the ad.

by Angela Maas

While HHS has taken multiple steps toward lowering prescription drug prices, the agency’s latest proposal has been its most contentious so far. And while it may succeed in providing consumers more information on drugs’ wholesale acquisition costs (WACs), industry experts wonder how effective it really will be in letting consumers know what they will pay for a drug.

The proposed rule would require direct-to-consumer (DTC) television ads for prescription drugs covered by Medicare or Medicaid that have a WAC of more than $35 per month to include that list price in the ad.

Barbara McAneny, M.D., president of the American Medical Association, said while the agency opposes DTC ads for prescription drugs, “as long as the practice is allowed, the ads should come with at least a small dose of transparency.…While this proposed rule alone won’t remove the often-misleading nature of prescription drug ads, it will give consumers a data point that is currently unavailable. That is a step in the right direction.”

And Frederick Isasi, J.D., M.P.H., executive director of Families USA, said, “Today’s announcement is a welcome step to rein in the cost of prescription drugs. People will be shocked to know how much their drugs really cost….This policy will focus public attention on the abusive prices charged by many pharmaceutical manufacturers.”

Others within the industry, however, question how effective the proposed rule, if implemented, would really be.

“Patients do not typically pay a drug’s list price at the pharmacy counter,” points out Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates. “Showing the average monthly list price in direct-to-consumer advertising may not be meaningful. It could also frighten some people enough not to take prescribed medication as directed, thinking that they would have to actually pay this amount. It is not possible for a manufacturer to show estimated out-of-pocket cost, because this is highly variable.”

In addition, he tells AIS Health, a different cost for a drug at the pharmacy than what is shown in an ad may confuse patients, making it likely that they’ll contact their providers’ offices, which will need to take the time to explain the discrepancy.

CVS Unveiled New Approach to Manage Specialty Drugs

September 19, 2018

At the time of year when PBMs are rolling out their 2019 strategies, CVS Health has unveiled a bold new approach to managing certain specialty drugs based on data from the Institute for Clinical and Economic Review (ICER). However, industry experts are divided on how much of an impact it truly will have on drug prices.

In a white paper out last month, CVS revealed that it’s starting a program focused on bringing down launch prices of pricey me-too drugs.

At the time of year when PBMs are rolling out their 2019 strategies, CVS Health has unveiled a bold new approach to managing certain specialty drugs based on data from the Institute for Clinical and Economic Review (ICER). However, industry experts are divided on how much of an impact it truly will have on drug prices.

In a white paper out last month, CVS revealed that it’s starting a program focused on bringing down launch prices of pricey me-too drugs. The approach allows clients to exclude those medications that come onto the market with a price more than $100,000 per quality-adjusted life year (QALY) as determined by publicly available ICER analyses. Drugs to which the FDA has given breakthrough therapy status will not be eligible for exclusion.

CVS’s approach is “another example of how payers and PBMs are looking at opportunities to manage drug costs by tying access to competitive cost-effectiveness,” according to Ami Gopalan, Pharm.D., vice president at Precision for Value. “As therapeutic classes become more competitive, encompassing multiple products with similar efficacy and safety, programs like the one promoted by CVS provide another option for formulary management.”

Yet Lisa Kennedy, Ph.D., chief economist at Epiphany, is more skeptical. “Already ‘me-too’ drugs are subject to negotiation such that they can be excluded from formularies — I’m not sure if this is going to have such a material effect on them,” she says. “The question is how this will affect innovative drugs where there are fewer alternatives for patients.…I can’t see a lot of benefits to this approach.”

“I’m not sure how this will affect products at launch, but it could function to put pressure on manufacturers not to raise their prices over time — this combined with competitive pressure,” Kennedy adds

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.