Adding essential asthma medicines onto national Essential Medicines Lists and lists of reimbursed medicines will improve access to these medicines and reduce the burden of asthma.
ACCESS TO QUALITY-ASSURED, AFFORDABLE ASTHMA MEDICINES
The World Health Organization (WHO) Essential Medicines List includes two inhaled corticosteroids (preventer inhalers) and one bronchodilator (a reliever inhaler) for asthma. A Global Asthma Network (GAN) survey shows that many countries do not have these WHO-recommended medicines on their national Essential Medicines List (EML), and many are not providing them free or subsidised for patients, especially in low-and middle-income countries. A number of medicine-related measures should be urgently addressed at a global and country level.
Targets for essential asthma medicines
WHO defines essential medicines as those that satisfy the priority health care needs of the population. They are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford. An EML is a government-approved selective list of medicines that guides: the procurement and supply of medicines in the public sector; schemes that reimburse medicine costs; medicine donations; and local medicine production. When properly resourced, it is a cost-effective means of providing safe, effective treatment for the majority of communicable and non-communicable diseases.
The WHO EML includes two inhaled corticosteroids: beclometasone 50 micrograms (µg) and 100µg, and budesonide 100µg and 200µg, as well as one bronchodilator: salbutamol 100µg. Corticosteroids are called ‘preventers’ because they act to prevent the chronic inflammation of the airways and reduce the twitchiness of the airways. They are recommended for persistent asthma, and are effective at reducing the number of attacks and severity of asthma symptoms. They need to be taken once or twice a day every day even when a person is free of symptoms, and reach peak effect after two weeks. Bronchodilators are called relievers because they relieve the spasm of airway smooth muscle which occurs when asthma symptoms appear. Salbutamol starts to work straight after inhalation and reaches a peak of effect after 20 minutes which lasts for about 4 hours.
Patients with a chronic condition such as asthma need a reliable uninterrupted supply of quality-assured medicines. They also need to be able to afford these medicines over the long term, not just for a one-time or short-term expenditure as for many communicable diseases. To provide for these patients, countries need to add essential asthma medicines onto national EMLs and/or reimbursement lists. Global targets have been established by WHO to encourage countries to improve access to quality-assured, affordable medicines for non-communicable diseases, including asthma (see Box), and GAN has created specific targets for asthma (see Summaries/Global AsthmaNetwork).
Global Asthma Network survey about essential asthma medicines 2014
GAN Principal investigators were surveyed in May 2014 with a brief questionnaire about the inclusion of WHO essential asthma medicines in two lists their countries may have: a national EML and a type of national reimbursement list (NRL) or similar, which lists medicines that are either fully or partially reimbursed by the government. Data were returned from 99 of 118 countries surveyed. The results are presented in the Table, with countries grouped as high-income countries (HICs) or low- and middle-income countries (LMICs). Results presented here should not be considered definitive. Some results may reflect a difficulty for health services to access and interpret information about these lists; some results would benefit from explanations about the specificities of individual health systems. Mostly, however, the outcome for the patient is the same – if the essential medicines they need have not been prioritised at national level, the patients will have difficulty accessing them and affording them.
Of the 99 responding countries, 79 (80%) have an EML, with an impressive 57 (97%) of the LMICs having an EML. However, the results show that the asthma medicines on WHO EML are not systematically included by all countries in their EMLs. Of the 79 countries that reported having an EML, 62 (78%) had one or more inhaled corticosteroid on their EML, and 68 (86%) had the bronchodilator salbutamol on their EML. However, a range of doses of inhaled corticosteroid is needed so that the appropriate dosage can be prescribed, for each level of disease severity. It is therefore of concern that only 16 (40%) HICs and 33 (56%) LMICs have the corticosteroid beclometasone 50µg on their EML, and only 16 (40%) HICs and 26 (44%) LMICs have beclometasone 100µg. The inclusion of budesonide was even lower: 9 (23%) HICs and 15 (25%) LMICs had the 100µg dosage; 12 (30%) HICs and 21 (36%) LMICs had the 200µg.
Of 73 countries that reported having a National Reimbursement List (NRL), 60 (82%) had one or more inhaled corticosteroid on the NRL. There was a marked difference between country income level regarding inclusion of corticosteroids on the NRL: 31 (94%) of the HICs versus 29 (73%) of the LMICs. There were 28 (70%) HICs but only 21 (36%) LMICs that included 50µg beclometasone; similarly, 27 (68%) HICs but only 19 (32%) LMICs included 100 µg beclometasone. Best reimbursed was salbutamol: 64 (88%) of the countries with an NRL included it; 31 (78%) of the HICs and 33 (56%) of the LMICs. Patients in HICs with some kind of national reimbursement scheme for improving access to medicines are faring best – for HICs with an NRL, 94% included both an inhaled corticosteroid and salbutamol.
In conclusion, although countries may have other dosages or formulations of these medicines, and other asthma medicines, in circulation, this survey shows that many countries do not have the WHO-recommended essential asthma medicines on their lists, and many are not providing them free or subsidised for patients, especially in LMICs. This situation is detrimental for patient access to medicines. It requires urgent attention and ongoing monitoring.
Measures to improve access
People often speak about high prices being a barrier to accessing medicines. However, there are in fact many factors that can affect the availability and affordability of quality-assured essential asthma medicines. Countries may need to work on how asthma medicines are addressed in their national policies, programmes, guidelines, budgets and teaching curricula, for example, as well as how medicines are procured and made available to patients. The following measures would improve access to quality-assured medicines:
- Include the essential asthma medicines in national EMLs and NRLs, and stop reimbursing inappropriate, unnecessary, and very expensive asthma medicines.
- Ensure EMLs and NRLs include products only propelled by hydrofluoroalkanes (HFA) , and that product strengths have been updated where appropriate (HFA propellants replaced chlorofluorocarbons, as required by the 1987 Montreal Protocol on Substances that Deplete the Ozone Layer).
- Check that national asthma management guidelines are based on medicines that are available and affordable, and that the guidelines explicitly address the need to ensure access to medicines at all levels of health care, and especially among poor and marginalised populations.
- Add essential asthma medicines to the list of the WHO Prequalification Programme (a centralised quality assessment initiative that has achieved greater access for millions of patients to quality-assured medicines for selected diseases).
- Standardise the dosages of active ingredients in combined inhalers marketed in both high- and low- and middle-income countries to facilitate quality assessment, procurement, prescribing practices and the achievement of affordable prices globally (see Quality of Inhalers for more).
- Harmonise quality requirements across the international reference documents such as the pharmacopoeias (see Quality of Inhalers for more).
- Facilitate the development of independent laboratories for the testing of generic products that are not already approved by a stringent regulatory authority or relevant global mechanism.
- Encourage low- and middle-income populations to demand quality-assured, affordable essential medicines for asthma as part of the health care provided by the government.
- Support in-country implementation of sustainable cost recovery programmes such as Revolving Drug Funds (after an initial capital investment, medicine supplies are replenished with monies collected from the sales of medicines). Such funds become self-financing and build demand for quality-assured, affordable essential asthma medicines.
- Monitor and strengthen country capacity in pharmaceutical policy and procurement.
- Monitor and publish on factors that influence availability, affordability, and access to essential asthma medicines.
Most countries have not included the essential medicines recommended by the WHO on their EMLs and most do not reimburse these asthma medicines. The main type of asthma preventer medicines which lead to improved asthma control (inhaled corticosteroid inhalers) are less commonly supported by governments than the short term reliever inhaler, even though reliance solely on the reliever does not reduce the burden of asthma in the long term (see Asthma Management in Low-Income Countries).
Governments in all countries should ensure that they have a list of essential medicines for asthma which includes both inhaled corticosteroids and a bronchodilator in dosages recommended by WHO, and that these are available, quality-assured, and affordable for everyone in their countries.