Pick up your jumbo pack of toilet paper –and health insurance too. What started as a quiet partnership between club warehouse wholesaler Costco and insurance giant Aetna has now expanded to include relationships in nine states with two more pending approval. Two years ago, the two joined forces to provide Costco Personal Health Insurance, a health insurance program that offers consumers five options in terms of medical and dental coverage. Costco sees the tie-up as a means of both diversifying into new product areas and providing “value” to customers via access to a provider network of more than 500,000 primary care and specialty physicians, discounted pharmacy drugs, and online wellness tools and programs. (The other big box store making serious noise about moving into healthcare is Walmart.) For Aetna, the expansion of the partnership shows its commitment to the so-called retail insurance market. One of the underpinnings of the Affordable Care Act is the individual mandate and creation of health insurance exchanges to provide consumers with medical benefits outside the confines of traditional employer-sponsored insurance. Many insurers believe that their future growth depends on enrollment in these exchanges; Aetna has been among the most aggressive in inking alliances or mergers that allow improved benefit designs for exchange users. And as Forbes points out, it’s not surprising Aetna might want to attract individuals who frequent Costco: demographic analysis of the big box’s membership base shows a solid of individuals and small business owners who are not only affluent but have relatively low risk health profiles. Of course, Aetna’s bet on the exchanges isn’t without risks. In the next few weeks, the Supreme Court will decide on the legality of the ACA, especially the individual mandate. If the law is struck down, there may be less appetite for retail insurance plans like the kind Aetna and Costco are offering.
- Read more on the partnership from Health Leaders Media
- Read about Walmart’s dive into healthcare here.
- A write-up on Aetna’s decision to become a health information company is here.
Medtronic sees value in real world evidence. Omar Ishrak, CEO of Medtronic, seemed to be channeling the Real Endpoints vibe during the company’s recent earnings call: “Delivering economic value is increasingly becoming a critical factor in today’s changing healthcare environment” he said. Ishrak’s company made news this past week, announcing two partnerships that will help it amass real world evidence tied to its devices. The first alliance pairs the device maker and Aetna; the goal of the US-centric deal is to collect real world evidence data on the utility of chronic disease management in diabetes and heart failure. But the company is also working with the government of Lombardy, the largest-population region in Italy, to produce effectiveness research and collect cost data related to Medtronic devices (again in the treatment of chronic diseases). In the past year we’ve seen a handful of pharmaceutical companies align with payers to get real world data: AstraZeneca has inked two deals, a European-focused alliance with IMS, and a US-centric partnership with Wellpoint and the state of Delaware; United Biosource/Medco meanwhile has formed partnerships with both Sanofi and Pfizer (which also has an alliance with Humana around diseases of aging and senior care.) But until the Medtronic announcement, we’d yet to see a device company acknowledge that for adequate reimbursement of both marketed products and pipeline assets, it’s becoming critical to have access to data showing real world utility. As has been true of the other RWE alliances, details of the financial commitment (on both sides) remain fuzzy. Medtronic’s announcement coincided with the company’s recent earnings report, in which Ishrak outlined ongoing efforts to double revenues in emerging markets. Certainly, as Medtronic uses the information from the alliances to create value-based products, it can use the knowledge to create products and pricing schemes that appeal to rapidly growing EM customers too. –HB and Ellen Licking
- Catch more from Elsevier’s Gray Sheet here ($)
- MedCityNews also covered the announcement.
Speeding to drug approval: Just ahead of the big oncology-palooza officially known as ASCO, the FDA issued draft guidance that could accelerate the pipeline for novel breast cancer treatments and Drs. Prowell and Pazdur published an accompanying perspective in the New Englad Journal of Medicine. The FDA guidance document proposes that for some pre-surgical treatments of high-risk early-stage breast cancers, pathologic complete response (pCR) may be a provisionary early-stage approval endpoint. Conventional methods of demonstrating long-term outcome include data on disease-free survival or overall survival, which understandably take years of follow-up to gather. In an accelerated model, the absence after pre-operative therapy of residual invasive cancer in resected breast samples and lymph nodes as demonstrated through a pCR assay has been shown to be a good prediction of long-term improvement, comparable to disease-free survival or overall survival. Using data from pCR assessments in clinical trials, the FDA guidance proposes that new breast cancer treatments may progress through the pipeline at a relative clip. That’s not to say companies using pCR as a surrogate endpoint won’t have to follow-up with confirmatory trials that verify the treatment’s efficacy and safety. According to FDA’s guidance, one acceptable approach would be to use one single trial for both accelerated approval and as the confirmatory study. Alternatively clinical benefit may be confirmed in another breast cancer setting. According to a note by Leerink analysts, the new guidance might benefit a number of companies who have breast cancer medicines in late-stage development, include Roche/Immunogen, Novartis and Onyx/Bayer. Companies with agents earlier in development –think Aveo or Medivation—might also benefit too.
- Read more from the Federal Register here.
- The NEJM perspective is here.
- UCSF weighs in on the new regulatory guidance and linkages to I-SPY trials.
Sugar rush. Sanofi’s long-acting insulin Lantus holds about 80% of the market for basal insulins, racking up sales of $5 billion in 2011. In an effort to build a lasting brand post Lantus’ patent expiry, the French drugmaker has since 2010 moved aggressively to transform itself into an end-to-end diabetes solutions provider. This includes diversifi (For more, see this IN VIVO piece from 2010.) But Sanofi has plenty of competition from Novo Nordisk and Eli Lilly, whose new insulin therapies are generating lots of buzz ahead of the annual ADA meeting. US regulators will make a decision about Novo’s Degludec by July 29, while European regulators are expected to weigh in early in 2013. Meanwhile recently reported Phase II data from trials of Lilly’s basal insulin LY260554 show it results in weight loss in patients. Given the close link between type-2 diabetes and obesity, even moderate weight loss could give Lilly market edge over other basal insulins. In diversifying its diabetes portfolio, Sanofi has licensed rights to experimental treatments such as Zealand Pharma’s Lyxumia and is exploring therapies to treat the side-effects of diabetes, including one of the leading causes of blindness, diabetic retinopathy. And it doesn’t stop there: diabetics can now download Sanofi’s iPhone-compatible glucose monitoring device.
- Read about Sanofi expanding diabetes treatments here.
- This IN VIVO piece explores the Sanofi strategy in greater detail [$ required]
- New data from Novo Nordisk and Eli Lilly is outlined here.