Is billing chilling biosimilar adoption?

BY Jim Frederick

The biosimilars wave is here. The lower-cost versions of such pricy biologic drugs as Humira and Remicade are set to bring serious savings in the coming years, as long as they can clear hurdles that trade groups and manufacturers have identified.

The National Association of Chain Drug Stores recently noted that branded biologic drugs could cost the U.S. healthcare system $120 billion by 2024, based on projections from Express Scripts. But a 2017 Rand report found $54 billion in potential savings from biosimilars in the next 10 years.

With the selling point of biosimilars being their lower price than an origin drug — they are roughly 10% to 15% less expensive than a biologic — a big part of biosimilar adoption is getting them reimbursed properly. The Association for Accessible Medicines and the National Association of Chain Drug Stores are lobbying Congress and the White House for a change in the Centers for Medicare and Medicaid Services’ policy on reimbursement for biosimilar medicines. Such a change, AAM reported, also could yield significant savings to U.S. taxpayers.

“CMS currently groups all biosimilars of a reference biologic under a single billing code and payment rate,” the group noted recently. “A variety of stakeholders have raised concerns that this policy undermines patient access to affordable biosimilar medicines and stifles the creation of a robust biosimilars market.”

Sheila Frame, vice president and head of North American biopharmaceuticals at Sandoz, maker of the first FDA-approved biosimilar Zarxio (filgrastim-sndz) recently highlighted the need for proper reimbursement for biosimilars.

“Unique reimbursement codes are necessary to foster a competitive marketplace and support direct and indirect cost savings that will make our health system more sustainable,” she said.


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Which area of the industry do you think Amazon's entry would shake up the most?

Savings take center stage for generics makers

BY Jim Frederick

The money saved by using generic drugs — and their impact on patient accessibility — is limited only by how much the health system can utilize them. That’s according to the latest numbers from IQVIA and the Association for Affordable Medicines.

In 2016, the most recent year for which figures are yet available, generics accounted for 89% of all U.S. prescriptions dispensed, but only 26% of the nation’s pharmaceutical bill, according to research giant IQVIA and AAM report. The organizations note that generics have saved the health system roughly $1.67 trillion in the last decade.

What’s more, the federal health system could wring billions more in savings out of generics if Medicare and Medicaid adopted payment policies that fully encouraged their use. AAM and the National Association of Chain Drug Stores note that a 1% increase in use of generics can save as much as $558 million. The savings would be $6.56 billion annually if Medicare and Medicaid were able to match Hawaii’s 82.7% generic utilization rate.

Beyond healthcare systems savings, generics offer an important value proposition to patients, 21% of whom have skipped filling a prescription for themselves or a family member in the last year due to cost, according to the Kaiser Family Foundation. AAM research has found that the abandonment rate for branded drugs is 266% higher than it is for generics — 90% of which have a sub-$20 copay, compared with 39% of branded drugs that do.

Because of the impact generics can have on patient health, generic manufacturers and service providers have made cost savings and improved adherence rates for healthier patients central to their mission and drug development efforts.

At FamilyWize, which negotiates discounts on prescription medications through the use of its free card and mobile app, chief pharmacy officer Ken Majkowski and president and CEO Joseph Sanginiti said they are using new partnerships and initiatives to focus on transparency and improving prescription affordability.

As a result, “prescriptions that patients may not have been able to afford are now more affordable,” Majkowski and Sanginiti said. “First-fill and subsequent fills are now more likely to occur. The end result: adherence.”

With high costs focused largely on specialty products, Jim Luce, executive vice president of sales and marketing at Bridgewater, N.J.-based Amneal Pharmaceuticals, said the company has “enhanced our focus on providing more and more complex, specialty, high-value pharmaceuticals products to the U.S. market. To date, we’ve had much success with these products and will continue on that pathway.”

Luce said the goal is to offer generic options for treatments that previously were not available or had limited availability. The company has plans to launch more than 100 products in 2018, many of which Luce noted were the first generic available or part of a small group of available generics.

“Our industry-benchmark R&D team is able to successfully file high-barrier-to-entry formulations and dosage forms,” Luce said. “This enables Amneal to bring an ever-increasing portfolio of life-changing medicine to the public at more affordable price points.”

Maple Grove, Minn.-based Upsher-Smith — which in 2017 was acquired by Japan’s Sawai Pharmaceutical — also is focused on building up its generic product portfolio and boosting lower-cost treatment options.

“We are committed to meeting the needs of our pharmacy partners by significantly increasing our pipeline of products to include new dosage forms, as well as more traditional and specialty products,” president and CEO Rusty Field said. “As always, we will continue to support programs and initiatives that enhance the important role played by pharmacists in advancing patient care and improving health outcomes.”


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Which area of the industry do you think Amazon's entry would shake up the most?
generics market pills

Generics market paints uncertain profit picture for industry

BY Jim Frederick

Is the generic drug industry a victim of its own success?

Since enactment of the landmark Hatch-Waxman Generic Drug Price Competition Act of 1984, which unleashed generic competition by setting limits on the patent life and market exclusivity of pioneer branded drugs, the explosive growth of copycat medicines has transformed the U.S. pharmaceutical market and saved trillions of dollars for consumers and public and private payers.

As of 2016, the last year for which full figures are yet available, generics accounted for 89% of all U.S. prescriptions dispensed, and are on track to reach market penetration levels exceeding 90% this year or next, according to New York City-based IQVIA, formerly QuintilesIMS. The insights company noted in a recent report that generics are set to account for 92% of prescriptions by 2021 as more drugs come off patent and payers look to generics and biosimilars as a way to reduce costs.

For generic drug makers and wholesalers — not to mention American consumers and pharmacy retailers themselves — the tsunami of generics has largely been a long-term bonanza. But it’s also spawned frenzied competition, scrambled predictable profit models and, at times, upended topline sales projections. And with the Food and Drug Administration focused on speedier generic drug approvals and lower prices, an increasingly crowded marketplace continues to upend expectations for sales and profit margins for all segments of the generic supply chain.

All signs point to the continuation of the long upward trend in generic utilization, albeit at a slower pace as generic market penetration matures and approaches saturation levels. However, cost savings and an upcoming new surge in branded-drug patent expirations should keep the growth engine humming. Industry insiders also note that generics will play a key role in keeping costs low as large portions of Americans get older.

“As the U.S. population ages and more patients face chronic disease, healthcare costs will grow faster than the economy or the government can sustain,” Maple Grove, Minn.-based Upsher-Smith president and CEO Rusty Field said. “In this environment, the use of generics will continue to increase, especially as the FDA has made it a priority to reduce the backlog of generic drug applications, and to get even more generics into markets [that are] without sufficient competition.”

Fueling the continued increase in generic utilization will be another round of expiring patents on pioneer medicines. Although the stream of patent expirations won’t approach the “patent-cliff” years of explosive generic opportunity earlier in the decade, the long-term outlook for generic makers remains solid as another crop of high-selling pharmaceuticals approach the end of their exclusive market protection.

“The impact of patent expiries over the next five years, while higher in absolute dollars, will be lower in percentage contribution than the past five years — and no single year will reach the level of 2012,” said Murray Aitken, executive director of the IQVIA Institute for Human Data Science. The slowdown in branded medicines losing patent protection and the rise of more me-too manufacturers vying aggressively for first-to-file approval, and marketing rights from the Food and Drug Administration, he said, will create “fewer opportunities and higher competition … [for] generic companies.”

Nevertheless, Aitken said, “The reduction in overall spending as branded medicines lose exclusivity is expected to total $143.5 billion in the next five years — more than 1.5 times the impact as in the past five years. This includes the estimated impact of biosimilars, which will contribute between $27 and $58 billion.”

Deflation nation
Despite the highly publicized — and highly controversial — sharp increases in price for some single-source generics in 2013 and 2014, overall generics have been on a steady long-term decline.

“A number of generic drugs have … undergone steep price hikes, but in general, generic prices, as a category, remain flat or falling,” said Allan Courkell, senior director of health programs at Philadelphia-based Pew Charitable Trusts.

Generic drug prices have been dropping since at least 2010, according to the Government Accountability Office. “They have fallen even in the face of high-profile exceptions,” noted a report from the website ProPublica and The New York Times, with “dozens of old generic drugs (having) risen in price in recent years, for reasons that include supply disruptions and competitors’ leaving the market.

“Despite these cases, the trend toward deflating generic prices appears to have accelerated as companies have more aggressively undercut each other’s prices,” the report added.

“Generic inflation began easing in 2015,” said Adam Fein, president of Philadelphia-based Pembroke Consulting and CEO of Pembroke’s Drug Channels Institute. “This was due partly to the FDA’s having cleared much of the backlog for new generic drug applications. The FDA’s actions show why generic inflation is unlikely to return soon.”

For the past several years, the agency has been working full-bore to clear out the backlog of generic approval applications. Bolstered by a major increase in funding generated by the Generic Drug User Fee Act of 2012, or GDUFA, the FDA’s Office of Generic Drugs hired hundreds of new staffers and dramatically accelerated its review and approval process. As a result, the agency approved or tentatively approved 835 generics applications in fiscal year 2016 — the most ever in a single year until 2017, when the agency set another record.

The increase in approvals comes as price deflation becomes more of the norm in the generics market.

“The overall market for mature generic drugs is deflating by about 10% per year. Many generic drugs have dropped significantly in price over the past four years,” Fein said.

“Surprisingly, the prices for about 1-in-5 generic drugs remain elevated. … Scott Gottlieb, the new head of the Food and Drug Administration, has prioritized actions that should squeeze the remaining generic inflation out of the system.”

Gottlieb, who took over as head of the FDA last May, has tasked the agency to speed up generic drug approvals as a way to boost market competition and lower drug prices, in line with the Trump Administration’s oft-stated plan to reduce pharmaceutical prices. “We’re looking to create competition where there isn’t competition,” Gottlieb said last year.

More competition means lower prices — which Fein notes that this also comes with side effects. “I expect generic drug deflation to continue — and possibly accelerate — over the next 12-to-24 months,” Fein said. “Payers and consumers
will be the ultimate winners, but the drug channel faces significant disruption.”

‘A new period of hyper-competition’
Increasing competition and the downward trend in generic drug costs have hammered profits for manufacturers and roiled topline sales and profit margins for wholesalers and pharmacy retailers. And though consumers have generally seen some benefit , it has not been quite as substantial as advocates would have liked.

“Since 2013, average out-of-pocket costs for all brand and generic prescriptions have decreased by $1.19, with … 2016 brand costs declining to $28.31 from $32.36 in 2013 and generics dipping to $5.54 from a high of $6.05 in 2013,” IQVIA reported in its outlook to 2021. “The … list price for brands averaged 12 times higher than the average out-of-pocket cost for patients in 2016 compared with three times higher for generics.”

The growing price differential — and Gottlieb’s marching orders for a more aggressive FDA approach to the review and approval of generic drug applications — present the retail pharmacy industry with
a challenge.

“The pharmacy industry has entered a new period of hyper-competition, driven partly by a plateau in the generic dispensing rate,” Fein said. “As the market matures, the pressures on pharmacy profits from generic drugs are intensifying.”

It’s no secret that the dwindling margins for generics and the uncertain outlook of a highly competitive market impact retail pharmacies.

Among the big players, CVS Health reported a 3.4% decrease in pharmacy same-store sales in its third quarter of 2017, which included the “negative impact of [approximately] 435 basis points due to recent generic introductions,” according to the company.

CVS Health also reported a slowdown in its specialty pharmacy business due in part to an “increase in generic dispensing within specialty.” However, the company noted, the growth of biosimilar versions of biotech medicines “decreases revenue, but benefits margin.”

In its third quarter, Camp Hill, Pa.-based Rite Aid reported a roughly 198-basis-point negative impact that it said was the result of new generic from new generic introductions in its fiscal 2017 third quarter.

Based on a market analysis by the discount pharmaceutical website GoodRx, retail drug prices for 92 mature and commonly prescribed generic drugs fell 2.4% on a weighted-average basis from mid-2016 to mid-2017. The deflation that Fein predicts will continue as Gottlieb’s FDA streamlines the approval process, and it also comes as generics manufacturers continue to consolidate. Among notable mergers this year, Amneal is hoping to complete its acquisition of Impax Labs.
What this means for the retail pharmacy industry, in a word, is uncertainty that will force retailers to anticipate the impacts that generics will have on their bottom lines.

“Further consolidation among generic manufacturers coupled with changes in the number of major brand-name drugs anticipated to undergo a conversion from branded to generic status may … result in gross margin pressures within the industry,” Walgreens Boots Alliance chairman and CEO Stefano Pessina said recently. “In any given year, the number of major brand-name drugs that undergo a conversion from branded to generic status can vary, and the timing of generic conversions can be difficult to predict, which can have a significant impact on retail pharmacy sales and gross profit dollars.”


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Which area of the industry do you think Amazon's entry would shake up the most?