Specialty Pharmacy

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.

CVS Unveils Chronic Kidney Disease Program

April 25, 2018

CVS Health Corp. recently unveiled an initiative aimed at improving the management of chronic kidney disease (CKD), a costly condition that affects millions in the United States.

CVS’s multipronged program incorporates, among other things, a focus on early disease identification and patient education. According to estimates from the Centers for Disease Control and Prevention, 30 million people in the U.S. have CKD. But many of them don’t realize it.

“Often, kidney disease has no symptoms until it’s pretty advanced,” Jennifer Martin,

CVS Health Corp. recently unveiled an initiative aimed at improving the management of chronic kidney disease (CKD), a costly condition that affects millions in the United States.

CVS’s multipronged program incorporates, among other things, a focus on early disease identification and patient education. According to estimates from the Centers for Disease Control and Prevention, 30 million people in the U.S. have CKD. But many of them don’t realize it.

“Often, kidney disease has no symptoms until it’s pretty advanced,” Jennifer Martin, vice president, program development at the National Kidney Foundation, tells AIS Health. “That’s why it’s so important for people to talk to their doctor and get tested, especially if they’re at risk.”

According to CVS, CKD represents a huge cost burden, costing Medicare nearly $65 billion a year for chronic kidney disease care, and another $34 billion directly related to dialysis patient care.

Martin explains that kidney disease cannot be reversed or cured, but if people find out early, they can work with their health care team to manage it and may be able to prevent it from progressing to kidney failure.

Part of CVS’s initiative includes a comprehensive home dialysis program that includes a clinical trial for a home hemodialysis device that CVS Health plans to submit to the FDA for market clearance.

“The home hemodialysis device we are developing has been designed with features intended to make home hemodialysis simple and safe for patients, in order to facilitate longer, more frequent treatments,” says Bruce Culleton, M.D., vice president and chief medical officer, CVS Specialty.

He further points out that this program expands the breadth of CVS’s enterprise assets, including home nursing, long-term care centers, pharmacy locations and payer relationships.

Medical Benefit Pharmacy Trend Saw Biggest Increase in Years

March 20, 2018

In 2016, commercial per-member pre-month (PMPM) medical benefit pharmacy trend underwent the largest jump in five years, according to Magellan Rx Management’s Medical Pharmacy Trend Report.

“Commercial PMPM trend was seven percentage points higher — 21%, a 62% difference — than the 13% average annual trend of the last five years,” said Casandra Stockman, Pharm.D., vice president of medical pharmacy strategy.

Increases in drug prices were the largest contributing factor driving the rapid growth.

In 2016, commercial per-member pre-month (PMPM) medical benefit pharmacy trend underwent the largest jump in five years, according to Magellan Rx Management’s Medical Pharmacy Trend Report.

“Commercial PMPM trend was seven percentage points higher — 21%, a 62% difference — than the 13% average annual trend of the last five years,” said Casandra Stockman, Pharm.D., vice president of medical pharmacy strategy.

Increases in drug prices were the largest contributing factor driving the rapid growth. Among the top 20 commercial categories, eight more than doubled in spend from 2012 to 2016.

According to Stockman, “94% of commercial medical benefit drug spend is from specialty medications, which is driven by only 10% of patients. For Medicare, 96% of drug spend is from specialty drugs driven by 21% of patients.”

Among commercial plans, the top five drugs in terms of spend are Remicade, Neulasta, Herceptin, Rituxan and Avastin, which have switched positions within the top five only twice in eight years. The programmed-cell death (PD)-1 inhibitor Opdivo became the first new drug that entered the top five Medicare drugs listing since the inception of Magellan’s report.

Stockman concluded that “medical benefit trend continues to outpace pharmacy benefit trend. Over the last five years, the average annual commercial medical benefit trend was 13% while the pharmacy trend was closer to 5%, reinforcing the need to diligently manage drugs covered by the medical benefit to help temper the accelerated costs.”

The report is based on surveys sent to medical, pharmacy and network directors from 46 commercial and Medicare Advantage payers representing more than 128 million covered lives, as well as analyses of commercial and Medicare Advantage health plan paid claims data.

Pharma Industry Experts Expect Medical Benefit Focus, Value-Based Contracts in 2018

February 22, 2018

AIS Health spoke with several industry experts about their expectations for management strategies and pricing of specialty drugs in 2018.

In terms of specialty drug management strategies, Martin Burruano and Amy Nash at Independent Health expect to see “increasing formulary management by disease state…, preferred specialty drugs within therapeutic classes and value-based contracting with specialty partners.”

Programs that “manage drugs covered under the medical benefit in addition to those that may fall under both medical and/or pharmacy benefits”

AIS Health spoke with several industry experts about their expectations for management strategies and pricing of specialty drugs in 2018.

In terms of specialty drug management strategies, Martin Burruano and Amy Nash at Independent Health expect to see “increasing formulary management by disease state…, preferred specialty drugs within therapeutic classes and value-based contracting with specialty partners.”

Programs that “manage drugs covered under the medical benefit in addition to those that may fall under both medical and/or pharmacy benefits” are likely to gain more attention, according to David Lassen at Prime Therapeutics LLC. He also predicts that payers will continue to look for means to better manage the specialty pharmacy expenditure across the medical benefit.

Thom Stambaugh, R.Ph., vice president for Cigna, suggests that integrated pharmacy and medical claims data will play a key role in determining the effective of certain drugs and avoiding unnecessary medical events.

President of PerformRx Mesfin Tegenu expects to see “a greater focus on outcomes-based contracting…[and] more comprehensive reviews/treatment algorithms for complex disease states.”

As the prices of specialty drugs have drawn a lot of attention in 2017, industry experts indicate that pricing will continue to be the front-page topic.

According to Burruano and Nash, specialty drug prices are likely to keep increasing. Meghan Oates-Zalesky of InCrowd sees the same trend, criticizing the current administration’s instability and “lack of consideration applied to the repeal of the individual mandate.”

Stephen Cichy of Monarch Specialty Group, LLC, expects more attention on specialty generics as well as a shift away from open specialty networks.

While less than 1% of the population in the United States accounts for one-third of total drug expenditures, the cost of certain therapies has contributed greatly to the unsustainability of the current health care model, Tegenu suggests. He points out that the key question is “how much are we, as a society, willing to pay for the benefits of certain drug therapies currently available and in development?”