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Orphan Drugs in Colombia: Practical Limitations to Access

By Ciaran Cassidy, Analyst

Email: ccassidy@partners4access.com

Colombia, like much of Latin America, is receiving attention from the pharmaceutical industry as an emerging market (1). Through the introduction of a universal healthcare system, it seems to provide an attractive opportunity for manufacturers. In this article we will review the Colombian healthcare system from an orphan drugs market access perspective.

The healthcare system and access to medicines

Universal health coverage insures~97% of 49 million citizens in Colombia (2).

Figure 1 Healthcare System Structure

Approximately 90% of Colombians are covered by the Sistema General de Seguridad Social en Salud (SGSSS) and 10% via private insurance (Prepagada), while the remaining are not insured and must pay out of pocket (3).

The SGSSS (social security scheme) provides both public and private service (IPS) coverage and is funded through general taxation and payroll contributions, which are pooled in the ADRES solidarity fund. All citizens registered on the SGSSS must select an EPS (Entidad Promotora de Salud), which acts as a health insurer and intermediary between patients and service providers (IPSs) (4,5). Municipalities themselves can perform purchasing functions through contracts with IPSs for services not covered by the Health Benefits Plan under the Capitation Payment Unit (PBSUPC), and for the uninsured (6).

Citizens covered by the SGSSS are covered by the PBSUPC, or Health Benefits Plan, which is the same for all citizens regardless of their affiliation to the solidarity fund (7). This list covers which health benefits the federal government’s Capitation Payment Unit (CPU) funding can be used for, and is updated by the MoH every year. Product inclusion is largely based on prevalence, cost-effectiveness, and safety. The list tends to cover products to treat diseases affecting large sections of the population rather than rare diseases, which physicians can access via the MIPRES prescription system but without CPU funding.

Colombia has a modern private healthcare system with expats buying health insurance from international and local providers. Many doctors in this system are trained in the USA or Europe and with high quality treatment Colombia’s private healthcare system is popular with medical tourists, particularly from the USA (8). Around 10% of Colombia’s citizens are covered by private insurance with monthly premiums varying based on age, chosen plan, and pre-existing conditions (9,10).

Drug pricing in Colombia

The Comision Nacional de Precios de Medicamentos y Disponsitivos Medicos (CNPMDM) is an inter-ministerial commission which annually sets the reference price for all medical products marketed in Colombia and oversees the design and methodology for regulating drug prices. The CNPMDM decision will take into account reports from the national HTA body, the Instituto de Evaluacion Technolgica en Salud (IETS), on topics such as cost-effectiveness, efficacy, safety, and budget impact (11,12).

The list price (of all drugs) is based on international/external price referencing using a 25th percentile benchmark of prices in 17 countries (13) (Argentina, Australia, Brazil, Canada, Chile, Ecuador, France, Germany, Mexico, Norway, Panama, Peru, Portugal, Spain, UK, USA, and Uruguay) (14).

The list price of a drug is regulated if 1 OR 2 and 3 are met from the following criteria (15).

  1. It is above the 25th percentile of the 17 reference countries, in which case it will be set at the 25th percentile
  2. It is considered a public interest for health reasons or has a high financial impact
  3. It has no therapeutic substitute, or a high market concentration compared to other drugs in the same therapeutic group

On top of this, the Ministry of Health (MoH) has the authority to establish mechanisms to undertake centralised negotiations and to directly purchase medicines, which indicates a potential for confidential discounts. Therefore, a strategic launch sequence leading up to Colombia can make a large difference to a product’s price potential.

Access to drugs in Colombia

In 2015 Colombia passed a statutory law, Law 1751, recognising citizen’s constitutional right to healthcare. This means that citizens can file a ‘tutela’ in the courts to enforce the government’s provision of healthcare, even if the EPS would not be able to finance this with CPU funding of the Health Benefits Plan.

In 2017 there were roughly 600,000 tutelas filed in Colombia with over 200,000 for health claims (32.54%) (16).

While this sounds like an alternative route for in particular rare disease patients to access appropriate treatment, to not be covered by CPU funding of the Health Benefits Plan, manufacturers should remain cautious:

1: Challenge tutelas head-on in court: If an EPS can argue that to prevent access to treatment would not cause a citizen’s health to deteriorate they seem to nullify the ‘right to healthcare’ argument and prevent a court enforcement.

2: Under dose patients to reduce their budget impact: To manage budgets but reimburse treatment for a broad range of patients, some EPSs will under dose (by reimbursing a dose lower than the label/requested) expensive therapies.

3: Stringent diagnostic requirements: In order to decrease budget impact an EPS may dismiss patients from treatment for concomitant indications, such as an infection, which are not thoroughly defined. It is also the case that some EPSs ask for extensive diagnostic testing and referral to geneticists before reimbursing treatment in order to filter out costly patients.  

4: Assigning or re-assigning patients to physicians far away from the patient’s home: In order to discourage access to expensive therapies, EPSs can assign patients to access treatments from difficult to reach hospitals/physicians which impacts compliance.

Therefore, while Colombia has broad access to healthcare through its health policies and judicial route it will be important for a manufacturer launching in Colombia to be aware of potential risks. Fostering close relationships with stakeholders by engaging early, manufacturers will be better placed to understand payers’ concerns and tailor value messages more effectively.  Access to medicines for all patients should remain a priority for all stakeholders involved in the system, collaborating to find a way forward will be essential. 

Partners4Access is an expert global consultancy specializing in access for orphan drugs, cell and gene therapy. If you would like support in your product candidate commercialization journey, please contact the team on contact@partners4access.com.


 

References:

1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5717296/

2: https://www.xcenda.com/insights/htaq-summer-2017-colombia-a-unique-universal-healthcare-model-in-latin-America) (https://data.worldbank.org/country/Colombia

3: https://www.xcenda.com/insights/htaq-summer-2017-colombia-a-unique-universal-healthcare-model-in-latin-America

4: https://www.social-protection.org/gimi/gess/RessourcePDF.action?ressource.ressourceId=48177

5: https://www.minsalud.gov.co/English/Paginas/ADRES-Assumed-FOSYGA-Ac

6: http://www.neuroeconomix.com/nuevo-pos-que-fue-lo-que-cambio/

7: https://www.sciencedirect.com/science/article/pii/B9780128115312000096

8: https://www.justlanded.com/english/Colombia/Colombia-Guide/Health/Private-and-public-health-care

9: https://medellinguru.com/health-insurance/

10: https://www.icesi.edu.co/proesa/images/GNHE%20UHC%20assessment_Colombia%204.pdf

11: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833155/#Fn1

12: https://press.ispor.org/LatinAmerica/2016/05/the-institutionalization-of-health-technology-assessment-in-colombia-advancements-and-future-challenges-2/

13:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833155/#Fn1

14: http://social.eyeforpharma.com/market-access/latin-americas-pharmaceutical-prices-perfect-storm-here

15: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5833155/#CR8

16: https://www.hhrjournal.org/2018/06/realizing-the-fundamental-right-to-health-through-litigation-the-colombian-case/

 

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