Amneal’s erythromycin tablets launch
Amneal on Tuesday received Food and Drug Administration approval for its erythromycin tablets, immediately launching the product. Amneal said that its generic is the only alternative oral release tablet on the market.
“Amneal is committed to increasing access to affordable medications,” Amneal executive vice president of commercial operations Andy Boyer said. “Erythromycin tablets are a great example of a product with limited availability where we can now provide patients and pharmacists with options.”
Amneal’s tablets are sold in 100-count bottles of 25- and 50-mg dosage strength tablets.
The product had a market size of roughly $84 million in the 12 months ended January 2018, according to IQVIA data.
Lupin intros Tydemi, its Safyral generic
Lupin has launched its contraceptive Tydemy, which was approved by the Food and Drug Administration in December as a generic of Bayer’s Safyral. Tydemy, (drospirenone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg) are indicated to preven pregnancy and raise folate levels in women who prefer an oral contraceptive.
The drug had U.S. sales of roughly $22 million for the 12 months ended January 2018.
Specialty pharmacy now runs the healthcare gamut
Specialty pharmacy is no longer simply set apart by the medication it dispenses. As a result of the patients it serves — whose conditions span disease states from oncology and rare diseases to cystic fibrosis and others that require high-cost, specialized medication — specialty pharmacy has expanded the scope of its services to patients, as well as payers, prescribers and manufacturers.
With specialty pharmacy operating as something of a hub at the center of the patient’s care continuum, companies in this segment are faced with various imperatives — offering personalized patient care and communicating with a patient’s care team, all the while managing costs and securing access to medications with limited distribution.
“Due to the complexity of caring for the specialty patient, a holistic approach is required to ensure that patients receive comprehensive clinical support, as well as access to medications,” Surya Singh, CVS Specialty chief medical officer, said. “In tandem, meeting these objectives helps to increase value through both outcome enhancement and lower costs.”
To deliver on these goals requires a new level of service on the front end, as well as robust back-end capabilities. At CVS Specialty, the care model is focused on proactively managing patient care, offering infusion care and implementing connected health tools.
“Our patients have access to a CareTeam, a team of specialized pharmacists and nurses who provide disease-specific support, including benefits verification, care coordination, comorbidity management and symptom management, while also providing emotional support to patients and caregivers,” Singh said. CVS Specialty’s offerings include digital tools aimed at training patients and boosting adherence, including on-demand communication with a patient’s CareTeam and reminders for lab testing, medication monitoring and safety. It also offers Specialty Connect, which lets patients access medication where they prefer, either by mail at home or at their local CVS Pharmacy.
Accessing new meds
Access to care goes beyond convenience for specialty pharmacies — it also includes making sure they are able to dispense new therapies that receive approval from the Food and Drug Administration. A key part of specialty pharmacies’ patient care strategy is being able to offer certain drugs in the first place, as many manufacturers will roll out new specialty treatments on a limited-distribution basis, making access a key competitive edge in the space. In 2017, US Bioservices, the specialty pharmacy of AmerisourceBergen, received access to 28 new products, including 10 in the oncology space and three treatments for rare and orphan conditions — which officials say requires being able to prove capabilities to manufacturers.
“Specialty pharmacies like US Bioservices are often a central touchpoint for the many stakeholders in the healthcare system,” Kelly Ratliff, president of US Bioservices, said. “So gaining access to limited-distribution products includes proving that you have expertise in all of those areas.”
Part of what Ratliff referenced makes US Bioservices a prime candidate for limited-distribution drugs are the offerings it has for manufacturers. As part of AmerisourceBergen, it can be part of a larger rollout strategy for a manufacturer that allows them to directly reach patients.
“We have the benefit of sitting in front of manufacturers with specialty distribution services, reimbursement services through Lash Group, clinical trial logistics solutions through World Courier, [strategic consultancy service through] Xcenda, as well as US Bioservices,” Ratliff said. “We can bring a suite of solutions to manufacturers that provide them with a nice commercialization approach.”
Beyond manufacturers, specialty pharmacy operators also build relationships with payers, who increasingly are seeking to manage the cost of specialty drugs, which made up roughly 39.6% of medicine spending in 2016, according to IQVIA. One of the first-line approaches is ensuring adherence, which Ratliff said follows when implementing a patient-centered care solution.
“We need to make sure that there’s value in the products that are dispensed,” Ratliff said. “Our services and solutions are designed to mitigate waste and monitor the patient’s clinical response, as well. While we don’t control the drug price, our job is to ensure that the drugs that are dispensed are taken as intended, and that we’re monitoring the outcomes of each of those therapies.”
For CVS Specialty, in addition to a focus on adherence, managing costs means leveraging its position as part of CVS Health’s integrated model. Singh said CVS Specialty is able to implement tools through pharmacy benefits manager CVS Caremark. This strategy includes managing which drugs it will pay for with a focus on value and outcomes.
“Formulary management is a cornerstone of cost control for payers and key to managing spend across traditional and specialty therapies,” Singh said. “We offer a range of formulary designs that integrate preferred drug, generic maximization and biosimilar strategies, and have more recently implemented value-based components, including indication-based formularies. Depending on payers’ incumbent formulary approach, our more advanced specialty formulary options can result in double-digit percent savings — independent of other management solutions.”
CVS Health also allows payers to employ an exclusive network strategy that includes its specialty and infusion networks as a means of highlighting lower-cost care sites and cost-effective dispensing. Additionally, it has implemented contracting strategies tying reimbursement to patient outcomes, as well as indication-based formulary management. “We also offer a range of utilization management programs, including step therapy and generics first strategies, to help ensure the right drug is being prescribed to the right patient at the right time, which can help to deliver up to 6% in savings,” Singh said.
The available options that a PBM-based approach can bring is part of what is driving Diplomat, the nation’s largest independent specialty pharmacy, to shake up its business strategy and position itself as a broader-based healthcare company. In late 2017, the Flint, Mich.-based company acquired two PBMs in as many weeks, buying up LDI Integrated Pharmacy Services and National Pharmaceutical Services.
“I always expected that Diplomat would be in the PBM space, but I did not expect that to happen until probably 2019 or 2020,” Diplomat’s recently retired CEO Phil Hagerman told investors when the LDI acquisition was announced. “But we believe that the market dynamics have shifted such that cost containment is critical to the marketplace today. And the only way to totally optimize all the levers around cost containment is to be able to work symbiotically and seamlessly across the PBM and specialty pharmacy and the specialty infusion space.”
As part of this approach, Diplomat said this year it would focus on advancing the use of generics, affordable brands and biosimilar medications, as well as increasing the number of drugs in its split-fill program by 78%, which president Joel Saban said has the possibility to save as much as 50% per patient by offering a two-week fill at the start of therapy to reduce waste if they need to switch therapies. The company also will be keeping an eye on the biosimilar market, which has seen slow adoption as approvals — and intellectual property lawsuits from original drug makers — trickle in.
“We view biosimilars as a key lever in managing the rising cost of specialty spend,” Diplomat interim CEO Jeff Park said. “Biosimilars have struggled to gain footing in the United States due to litigation. However, we expect the environment to become more favorable soon. This should lead to expanded biosimilar use and more affordable care.” CVS Specialty’s Singh also said that biosimilars play a role in its cost-containment strategy.
With all of the hats that specialty pharmacy companies wear, the focus stays on patients in a way that builds on a pharmacist’s already large role in a patient’s therapy, US Bioservices’ Ratliff said.
“It really does elevate the practice of pharmacy to a little bit of a different level,” Ratliff said. “I’m a pharmacist by background, and when I think about the pharmacist’s traditional role, that’s still important to us, and patient counseling related to the drug is important to us, but our role goes beyond that — we become a patient advocate between their insurance company and their prescriber. Our role really is connecting the entire scope of the patient’s treatment regimen — not just providing services related to the drugs that we dispense.”