US patient assistance programmes - a critique

Financial support given to patients is receiving more demand in the US, totalling an estimated $15 billion, but are patient assistance programmes good for either patients or pharmaceutical companies, and what effect will Obamacare have?

Pharmaceutical companies are recognised for their corporate social responsibility programmes. In the US, one of the ways companies engage in helping society is through company-sponsored patient or prescription assistance programmes, known as a PAPs.

These programmes provide assistance to many Americans, who are often unable to afford their prescription medications, whether they have insurance coverage or not. Contributing to this dilemma is the cost of prescription drugs, which increased an average 3.6 per cent from 2000 to 2009. During that same time period, the number of prescriptions increased 39 per cent. As a result, US spending for prescription drugs was $234.1 billion, nearly six times more than in 1990.1

A 2011 report from the US Consumer Reports National Research Center shows that 60 per cent of patients who take medication have addressed cost with the doctor or changed their lifestyle to afford their prescriptions - spending 22 per cent less on groceries, for example. Paying for prescriptions was a significant problem for patients whose spending for prescriptions was greater than $50 a month.2

Significant investment to bridge the insured/uninsured gap

Patient assistance programmes offered by pharmaceutical manufacturers provide eligible patients help to access medications for free or at minimal charge. Specific eligibility requirements differ by manufacturer, but typically patients must meet requirements such as US residency, no prescription coverage, low income and/or long-term drug needs.3

Patient assistance programmes provide help for patients to get access to their prescriptions in several ways. For example, Sanofi-Aventis assists patients seeking reimbursement from their healthcare insurance company, through verification services, claims management and appeals assistance, coding and billing assistance, and prior authorisation support. Additionally, there are programmes with counsellors who work with the patients to determine alternative ways to reduce a patient's cost, such as co-pay assistance, prescription saving programmes and patient advocacy groups.4

The scope of these contributions is quite significant. For example, the Boehringer Ingelheim Cares Foundation PAP helped more than 69,000 patients in 2011.5 Partnership for Prescription Assistance, sponsored by America's biopharmaceutical research companies, estimates that its programmes helped eight million Americans since it was launched in April 2005. It is estimated that around $5 billion is spent for patient assistance programmes. When the samples given to doctors' offices are taken into account (between 65 per cent and 75 per cent of the samples are given to uninsured patients), the entire support is estimated at $15 billion.6

Complex access precludes many patients

Despite the significant investment in patient assistance programmes, the complexity of accessing them precludes many patients from realising their benefits. Chauncey and others described the complexity of the application process. Documents such as income tax returns must be mailed/faxed to the specific programme address and be signed by both patient and prescribing physician. When a patient is approved to receive medication, the patient's prescription is sent to the physician's office for the patient.

To add to the complexity, many patients using patient assistance programmes need multiple medications and have to complete more than one application, especially for the most requested drugs for chronic medical conditions, such as diabetes, dyslipidemia and hypertension.7 In 2011-2012, 35 per cent of PAP administrators implemented advanced technology - electronic document imaging, for example - to increase programme access and efficiencies. However, the application process remains challenging for patients, who are often reluctant to tell their physician they are not able to pay for their drugs or are unable to complete the documentation requirements.

Assistance programmes - are they really marketing strategies?

There is still some scepticism about why pharmaceutical companies have introduced and remain involved with patient assistance programmes.8 The simplest answer is they are reaffirming a company's charitable orientation along with establishing a brand's identity. Furthermore, in the environment of restricted ability to reinforce a new drug with prescribers under the PhRMA Guidelines, patient assistance programmes are a legitimate alternative to giving free samples, coupons, co-pay assistance cards and rebates to reduce the cost of a patient's drugs.9 While this provides genuine assistance to a patient, it also enables a patient to start long-term therapy with a drug.

Patient assistance programmes can be considered to be part of a broader marketing strategy to convince patients remain on the company's branded product rather than switch to an alternative. Notwithstanding pharmaceutical companies' marketing incentives for doing patient assistance programmes, recent reports show a rising demand for those programmes, especially among the under-insured.10

Assistance programmes and Obamacare

As the US has begun the implementation of the Affordable Care Act (Obamacare), there is considerable uncertainty about what effect it will have on patient assistance programmes. Obamacare proposes to close the Part D coverage gap, where the PAPs are often used. It is also intended to expand access to healthcare insurance for the uninsured and under-insured, two key groups who are current benefactors of patient assistance programmes. Obamacare requires 'qualified health plans' to have some drug plan as an essential health benefit, so the use of patient assistance programmes may be influenced by the levels of new prescription coverage.11

Obamacare will also have consequences for pharmaceutical companies and administration of their programmes and charitable foundations. There will be a need to change how pharmaceutical companies design, implement and fund their programmes because patients, who do not qualify for patient assistance programmes, will still need drugs for free or at a reduced cost. Drug companies may also convert their PAPs into co-pay, cost-sharing or discount schemes along with the need to change the eligibility criteria for participation.6, 12

It seems likely that patient assistance programmes will evolve into something more than access to brand medications in post-Obamacare reality. For example, PAPs can build the knowledge portals for patients to remain compliant with their prescribed drug regimen and gain the best results of the therapy. Programmes can also consider integrating health economic outcomes research. Pharmaceutical companies can adapt their patient assistance programmes into something that not only assists patients' access to medications but also helps society and healthcare reform in the US.

References

1. Kaiser Family Foundation. 'Prescription drug trends' http://kaiserfamilyfoundation.files.wordpress.com/2013/01/3057-08.pdf

2. Consumer Reports National Research Center, Consumers Union of US Inc. 'Best buy drugs prescription drug-tracking poll 3', 2011 http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/2011-BBD-Rx-poll-public-release.pdf

3. Volunteers in Health Care. 'Using pharmaceutical company assistance programs' http://s3.amazonaws.com/www.rxassist.org/docs/using-pap-programs-manual.pdf

4. Sanofi. 'Sanofi patient connection' http://www.sanofi.us/l/us/en/layout.jsp?scat=FA582E76-C4AF-453B-BE47-228829600888

5. Boehringer Ingelheim. 'Patient and family assistance' http://us.boehringer-ingelheim.com/our_responsibility/patients-families.html

6. Suzanne Shelley. Pharmaceutical Commerce, February 26, 2013. 'Pharma struggles to manage the complexity of its patient assistance programs' http://pharmaceuticalcommerce.com/brand_communications?articleid=26770

7. Chauncey D, Mullins CD, Tran BV, and others. 'Medication access through patient assistance programs' American Journal of Health-System Pharmacy, 2006, volume 63, number 13, pages 1,254-1,259. http://www.ajhp.org/content/63/13/1254.citation?related-urls=yes&legid=ajhp;63/13/1254

8. Choudhry NK, Lee JL, Agnew-Blais J, and others. 'Drug company-sponsored patient assistance programs: a viable safety net?' Health Affairs, 2009, volume 28, number 3, pages 827-834.

9. Sillup G, Makowska M. 'Different healthcare systems influence marketing practices by pharmaceutical companies' pharmaphorum, September 6th, 2013. https://pharmaphorum.com/articles/different-healthcare-systems-influence-marketing-practices-by-pharmaceutical-companies

10. Financial Times. 'Downturn fuels demand for free drugs in US' http://www.ft.com/cms/s/0/f72726ec-40cf-11df-94c2-00144feabdc0.html#axzz2j2luZD4y

11. Chu CF, Lal LS, Felder TM, Rosenau P. 'Evaluation of patient assistance program eligibility and availability for top 200 brand name and generic drugs in the United States' Innovations in Pharmacy, 2012, volume 1, number 71, pages 1-9 http://purl.umn.edu/122764

12. Looney W. 'Patient assistance programs: are they still relevant?' PharmExecBlog, March 12th, 2012 http://blog.pharmexec.com/2012/03/12/patient-assistance-programs-are-they-still-relevant/

About the authors:

Marta Makowska, Ph.D., M.A.

Dr. Makowska is an Assistant Professor at Warsaw University of Life Sciences in Poland. In 2013 as recipient of a Mobility Plus Fellowship, she was a Visiting Scholar in the Pharmaceutical & Healthcare Marketing Department at Saint Joseph's University in Philadelphia. In 2004, she graduated with a Master's of Arts in Sociology and, in 2010, she finished Graduate School of Social Sciences where she defended her dissertation entitled: Ethical Standards of Pharmaceutical Marketing. A few months later she published a book by the same title, the first on this subject in Poland, and received first prize in the Federation of Financial Companies and Kozminski University Verba Veritatis contest for the best thesis in business ethics.

Dr. George P Sillup

Dr. Sillup is currently the Chairman of Pharmaceutical & Healthcare Marketing and Fellow in the Pedro Arrupe Center for business Ethics at Saint Joseph's University following 28 years of work in the diagnostic, pharmaceutical and medical device industry where he held positions from salesman to COO. During his industry tenure, Dr.Sillup has attained favourable reimbursement coverage and coding to support product launches in the US and global markets and monitoring how implementation of healthcare reform will impact healthcare delivery in the US.

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