JP MORGAN 2015: AstraZeneca US president on sales and reimbursement
This article was originally published in Scrip
AstraZeneca US president Paul Hudson has a unique perspective on product sales and reimbursement considering he's worked for the company in the UK, Spain and Japan during the past eight years.
"I'm acutely aware of the organization's responsibility to demonstrate value [of new medicines], having worked in challenging markets," Mr Hudson told Scrip in an interview during the 33rd Annual JP Morgan Healthcare Conference from 12 to 15 January in San Francisco. He pointed to newly-approved ovarian cancer drug Lynparza (olaparib) as a prime example of added value for the health care system and as a metaphor for AstraZeneca's latest resurgence.
CEO Pascal Soriot noted during the company's Investor Day in November that when he joined the company in October 2012 analysts wrote off AstraZeneca as a company in decline with anticipated revenue of $20bn in 2020, but Mr Soriot proclaimed that AstraZeneca is now on its way to selling $45bn worth of medicines by 2023 (scripintelligence.com, 19 November 2014).
Lynparza resurrected
Similarly, the company wrote off Lynparza in late 2011, because it did not have a significant impact on overall survival in a broad population of ovarian cancer patients (scripintelligence.com, 20 December 2011). But Mr Hudson, who was appointed to head up AstraZeneca in the US soon after Mr Soriot joined the company, notes that the CEO took the advice of an entrepreneurial AstraZeneca scientist who noticed that the drug performed well in certain cancer patients and the new CEO sanctioned further studies in patients with BRCA mutations (scripintelligence.com, 4 September 2013).
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor, a class of drugs that patients have been eager to try, because they appear to have less severe side effects than chemotherapy with better efficacy in patients with BRCA mutations (scripintelligence.com, 5 June 2013).
"Women are getting access to treatment when they thought they had no options left," Mr Hudson said.
AstraZeneca's drug was approved by the US FDA in December as a fourth-line treatment for patients with advanced ovarian cancer who have germline BRCA mutations that are detected by a test from Myriad Genetics, which was approved at the same time as Lynparza (scripintelligence.com, 20 December 2014).
Mr Hudson said the first few weeks of US sales look "absolutely amazing," because there were patients waiting for the drug to hit the market. The approved US indication amounts to only a few hundred women, but it appears that many of them accessed Lynparza immediately.
The drug is just one of five new product launches that Mr Hudson oversaw in the US during the past year and more are expected in 2015, including Movantik (naloxegol) for opioid-induced constipation (OIC) in adults with chronic non-cancer pain. The FDA approved Movantik, developed in partnership with Nektar Therapeutics, in September and AstraZeneca intends to launch the drug in March (scripintelligence.com, 17 September 2014).
Making the case for value
In terms of the value these new drugs provide to patients, which should justify their cost to payers, Mr Hudson points to Movantik's ability to help severely constipated patients have a bowel movement six to 12 hours after they take the drug. They don't have to live with the pain of constipation just to stay on the opioids that relieve other, more severe pain.
In terms of Lynparza, its companion diagnostic ensures that only patients with the highest likelihood of responding to the drug are treated with the PARP inhibitor. That keeps non-responding patients from wasting crucial time and it keeps payers from wasting money on ineffective therapies.
"I like to talk to payers and providers about how we're only looking at patients who will respond. It makes a big difference on cost to the health care system," Mr Hudson said.
He noted that a health care provider he met with recently has implemented an initiative to get the right cancer patient to the right treatment regimen faster than ever before. The strategy is in line with the Patient Protection and Affordable Care Act, the US health care reform law, which gives doctors financial incentives to achieve better outcomes for patients versus the old fee-for-service payment system that rewarded physicians for prescribing more tests and more treatments.
In cardiovascular disease, one of AstraZeneca's great hopes relies on the company being able to make the case for value to the health care system. AstraZeneca's 2023 revenue forecast counts on $3.5bn in sales from the antiplatelet therapy Brilinta (ticagrelor), which generated $343m during the first nine months of 2014, representing 78% growth from the same period in 2013.
The company reported on 14 January that Brilinta plus aspirin performed better than placebo plus aspirin in the 21,000-patient long-term outcomes study known as PEGASUS-TIMI 54. The clinical trial evaluated the drug's ability to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) for one to three years after a heart attack (scripintelligence.com, 14 January 2015). The data could be used to justify Brilinta therapy beyond the approved one-year treatment period.
Since PEGASUS-TIMI was placebo-controlled, it did not establish a long-term benefit over Brilinta's biggest competitor – Sanofi's now-generic Plavix (clopidogrel). That may be fine, however, since clopidogrel's safety over a longer treatment period hasn't been established.
"It is unclear how the results in these patients would compare to generic clopidogrel, though clopidogrel has not demonstrated consistent efficacy in this setting. Based on Brilinta's [prior Phase III] ACS study against clopidogrel, it should be more effective here too, but the question is how much it might increase major bleeding (there was only a slight increase versus clopidogrel in the ACS study)," Sagient Research said in a 14 January BioMedTracker analysis.
Real world value
Mr Hudson said it has been a "labor of love" to study the effects of Brilinta over the long term and reinforce its efficacy in ACS. He's also been an advocate in the US for educating patients about the importance of taking their medication every day so that the drug has the intended effects on cardiovascular outcomes. AstraZeneca has an ongoing agreement with a health care provider in which they're working together to enforce Brilinta adherence and improve patient outcomes.
"Payers say, 'A pivotal study is fine, but in real life this is not the type of patient we see,'" Mr Hudson said.
But payers pay attention if drug makers can show their cardiovascular medicines reduce hospital readmissions over time or if they can demonstrate that diabetes drugs have lasting effects on weight reduction, blood pressure and other factors.
With the increasing focus on prevention and outcomes, Mr Hudson has a lot of confidence in the US health care system to lower costs and improved care, based on his experience with systems in other areas of the world.
"If we get all of these things right, the US health care system has the best chance of success. All of the pieces are there," he said, to make it work.