Joint Statement by 16 cancer societies on 13 DEC 2021 in Kuala Lumpur
Medicines Price Regulation. “Nothing Without Us”.
Failure to Consult Cancer Patient Groups in the CBA 2.0 Study.
We, the undersigned 16 cancer societies led by Together Against Cancer (TAC) and the Prostate Cancer Society Malaysia (PCSM) raise doubt and express disapproval of the recently presented preliminary findings of the Cost-Benefit Assessment (CBA) 2.0 on the impact of the Medicines Price Regulation (MPR) policy.
Although the study summary stated that patient advocacy groups had been approached for 'expert views', none of our societies was invited.
Cancer medicines are among the most expensive in the market. Many of our members are experiencing financial hardship coping with the treatment costs, with medicine price as one significant determining factor. Under the 12th Malaysia Plan, Strategy B2, “Ensuring Financial Sustainability for Healthcare,” spells out explicitly: “a price control mechanism for medicines will be introduced to protect consumers from unfair pricing” (Page 4-22). The government clearly knows the issue and attempts to address the medicine pricing concern.
The Medicines Price Regulation policy is fundamentally a public health and consumer affairs policy first and foremost, hence rightfully spearheaded by the Ministry of Health (MOH) and Ministry of Domestic Trade and Consumer Affairs. Public consultation on the CBA 1.0 was held on 4 January 2021 for the patient and consumer groups and NGOs.
We are very disappointed with how the CBA 2.0 was conducted. The fact is that the CBA 2.0 primarily chose to overlook the impact on the most affected stakeholders (i.e. patients and their families) on the demand side but instead on the exaggerated claim of loss to the private industry on the supply side. Who plays victimhood here, who needs the medicines more? For whose interest and where is the objectivity of the study? The CBA 2.0 study is too biased towards the views of the private healthcare industry and even funded by them, suggesting a massive conflict of interest.
Confusion involving the private primary care sector, where the Phase 1 MPR policy likely will not affect, further confuses the picture. CBA 2.0 is framed as if the proposed policy will be taking away the narrow margin of the private primary care sector and threaten their survival. We want to focus on expensive, unaffordable cancer drugs that are not even free or subsidised in the government sector, which the MPR policy attempts to address.
According to the National Cancer Registry Report 2012-2016, males and females in this country have a lifetime risk of 1:10 and 1:9 respectively of cancer. In 2019, MOH and private hospitals treated 123,848 and 49,364 cancer patients and recorded 7,031 and 1,166 deaths, respectively (Health Indicators 2020).
A significant number of patients in the community need cancer drugs every day to stay alive. According to the Medicine Prices Monitoring Report 2017, cancer drugs stood out as one of the most expensive drug treatments by disease category. For example, Gefitinib and Trastuzumab, a Her2 type breast cancer drug, would require 190.8 and 551.7 days of wages (in the minimum wage category) for just one course of treatment.
Very interesting to note that the original Trastuzumab Herceptin came down in price by 50% from close to RM7,000 per month to RM3,000 per month in 2017 when biosimilars or generics came into the Malaysian market. Imagine if the average cost of Trastuzumab biosimilar cancer drug per treatment course is RM3,000. This would already cost the government and society about RM400 million per year just for one type of drug treating breast cancer patients in Malaysia; what more with higher markups at different distribution levels?
Ms Crystal Ng, a TAC Committee member, has shown that to continue to survive Stage 4 Her2 type breast cancer. She needed to spend RM8,870 every three weeks for Her2 drug TDM1 (Kadcyla) alone. The price does not include other costs such as Pirimat, Dexamethasone, Heparinised Saline, Chlorhexidine, doctor's consultation, nursing fee, etc. She has spent a total cost of RM168,503 of TDM1 (Kadcyla) alone for 19 cycles so far; how many Malaysian households could afford the treatment like this? Crystal chose to continue treatment in the private sector because the cost of the innovators is similar in the government hospital. It shows that even in the MOH hospital setting, many cancer drugs are not provided or listed in the MOH Medicines Formulary because they are too expensive.
We also found that some oncologists do not even inform the patients that they have a choice of expensive but efficacious drugs that could extend the lives of the cancer patients. Ms. Chang Chu San, a government teacher, was not given any option by a MOH hospital and a MOE hospital when her breast cancer recurred in her liver in 2014. When she consulted a private oncologist, she was informed of life-saving drugs (Herceptin and Kadcyla) that have kept her alive since then. She has spent close to RM177,200 (now 81 cycles) with the assistance of a compassionate programme, and after seven years, she continues to pay for lifelong treatment. She has since retired this year and leads a very active, fulfilling life. This is not acceptable for any contributing member of society to have lives cut short if not for these life-saving drugs.
In PCSM, some of their patient members have their lives unnecessarily shortened due to overpricing of medicines. Some medicines are so costly that only the wealthy could afford them, leaving the majority of the patients either facing financial catastrophe or opting out. PCSM recognise that the cost could be flexible among the drug manufacturers, as the cost price for the drug is just a fraction of the sale price, especially with drugs that have been in the market for a while but enjoy monopoly due to patents or only one or two generic suppliers. Also, there are equally efficacious generics elsewhere in the world in some cases, which could be obtained through limited supply personal imports.
Unfortunately, with wholesalers and retailers' current 'middleman' system, the markups at different levels would likely 'eat up' the supposed savings for the patients and families. Just to give one example, prostate cancer has an efficacious drug called Abiraterone acetate, priced at RM7,500 per month originally. PCSM fought hard for years to get accessibility of cheaper generics. Finally, a generic came to Malaysia two years ago, promising a lower price, but since it was a monopolised market, it was priced at RM4,000 (although it costs only RM800 in India). PCSM appealed to MOH to get a second generic. Before the generics arrived in Malaysia, PCSM had negotiated directly with the manufacturer as their members could only afford RM1,400. The manufacturer agreed and brought down the market price to the more affordable level exclusively for their members. But the other Malaysians are not so lucky. They have to go to the 'common market', either in the public or private hospital, where the costs range from RM2,400 to RM3,500. This shows the significant massive extent of the markup to the final price. PCSM has more than 50 members using the second generic, and the numbers are growing. From their experience in Malaysia with 350 prostate cancer survivors, some members managed to extend their lives and quality of living by an average of two years. How can anyone object to the regulation of markups that can prolong lives?
The lesson from the abovementioned stories is that patient advocacy organisations such as TAC and PCSM play a vital direct role in safeguarding the best interest of the demand side (the patients). Reducing the wholesalers and retailers' markups can achieve more affordable or favourable medicine pricing. Also, the Abiraterone acetate story told us, generic competition is the key to bringing affordable medicines to the patients.
For Phase 1 of MRP, only prescription drugs with a single registration holder in the Malaysian market (about 600 drugs) will be subjected to MRP, as single-sourced medications are usually most expensive due to market monopoly. Phase 1 will be monitored and reviewed before proceeding to the next phase. Transparency of the pricing that will be compared to external pricing of countries with similar GDP is good practice to ensure reasonable pricing for the patients in Malaysia. That is fair to the industry and private healthcare sector, which MOH always consults.
Therefore, we call for the government to implement the 1st phase of the MPR as soon as possible and urge the proponents of the CBA 2.0 to re-focus on implementing the 1st phase in line with the CBA 1.0. Stop using the victim card and stop exaggerating the numbers to include drugs outside Phase 1 in the CBA 2.0 study. If they genuinely care for their patients, the private healthcare industry also shouldn't make excessive profits at the expense of the patients, forcing them to fall into financial catastrophe or impoverishment. Instead, they should comply and lower their markup margin for costly drugs while still making a reasonable profit while changing their strategy to provide access to all patients, hence earning more by increased sales volume. Furthermore, it is reassuring that Europe, Australia, New Zealand, Canada, Indonesia, Thailand, India and China practice medicine price control.
We, the cancer patients, are very hopeful that cancer drugs can be made more affordable. Hence, we hope with regulated price control, more people can access and, through the economy of scale, bring reasonable profits to all parties.
Endorsed by:
Failure to Consult Cancer Patient Groups in the CBA 2.0 Study.
We, the undersigned 16 cancer societies led by Together Against Cancer (TAC) and the Prostate Cancer Society Malaysia (PCSM) raise doubt and express disapproval of the recently presented preliminary findings of the Cost-Benefit Assessment (CBA) 2.0 on the impact of the Medicines Price Regulation (MPR) policy.
Although the study summary stated that patient advocacy groups had been approached for 'expert views', none of our societies was invited.
Cancer medicines are among the most expensive in the market. Many of our members are experiencing financial hardship coping with the treatment costs, with medicine price as one significant determining factor. Under the 12th Malaysia Plan, Strategy B2, “Ensuring Financial Sustainability for Healthcare,” spells out explicitly: “a price control mechanism for medicines will be introduced to protect consumers from unfair pricing” (Page 4-22). The government clearly knows the issue and attempts to address the medicine pricing concern.
The Medicines Price Regulation policy is fundamentally a public health and consumer affairs policy first and foremost, hence rightfully spearheaded by the Ministry of Health (MOH) and Ministry of Domestic Trade and Consumer Affairs. Public consultation on the CBA 1.0 was held on 4 January 2021 for the patient and consumer groups and NGOs.
We are very disappointed with how the CBA 2.0 was conducted. The fact is that the CBA 2.0 primarily chose to overlook the impact on the most affected stakeholders (i.e. patients and their families) on the demand side but instead on the exaggerated claim of loss to the private industry on the supply side. Who plays victimhood here, who needs the medicines more? For whose interest and where is the objectivity of the study? The CBA 2.0 study is too biased towards the views of the private healthcare industry and even funded by them, suggesting a massive conflict of interest.
Confusion involving the private primary care sector, where the Phase 1 MPR policy likely will not affect, further confuses the picture. CBA 2.0 is framed as if the proposed policy will be taking away the narrow margin of the private primary care sector and threaten their survival. We want to focus on expensive, unaffordable cancer drugs that are not even free or subsidised in the government sector, which the MPR policy attempts to address.
According to the National Cancer Registry Report 2012-2016, males and females in this country have a lifetime risk of 1:10 and 1:9 respectively of cancer. In 2019, MOH and private hospitals treated 123,848 and 49,364 cancer patients and recorded 7,031 and 1,166 deaths, respectively (Health Indicators 2020).
A significant number of patients in the community need cancer drugs every day to stay alive. According to the Medicine Prices Monitoring Report 2017, cancer drugs stood out as one of the most expensive drug treatments by disease category. For example, Gefitinib and Trastuzumab, a Her2 type breast cancer drug, would require 190.8 and 551.7 days of wages (in the minimum wage category) for just one course of treatment.
Very interesting to note that the original Trastuzumab Herceptin came down in price by 50% from close to RM7,000 per month to RM3,000 per month in 2017 when biosimilars or generics came into the Malaysian market. Imagine if the average cost of Trastuzumab biosimilar cancer drug per treatment course is RM3,000. This would already cost the government and society about RM400 million per year just for one type of drug treating breast cancer patients in Malaysia; what more with higher markups at different distribution levels?
Ms Crystal Ng, a TAC Committee member, has shown that to continue to survive Stage 4 Her2 type breast cancer. She needed to spend RM8,870 every three weeks for Her2 drug TDM1 (Kadcyla) alone. The price does not include other costs such as Pirimat, Dexamethasone, Heparinised Saline, Chlorhexidine, doctor's consultation, nursing fee, etc. She has spent a total cost of RM168,503 of TDM1 (Kadcyla) alone for 19 cycles so far; how many Malaysian households could afford the treatment like this? Crystal chose to continue treatment in the private sector because the cost of the innovators is similar in the government hospital. It shows that even in the MOH hospital setting, many cancer drugs are not provided or listed in the MOH Medicines Formulary because they are too expensive.
We also found that some oncologists do not even inform the patients that they have a choice of expensive but efficacious drugs that could extend the lives of the cancer patients. Ms. Chang Chu San, a government teacher, was not given any option by a MOH hospital and a MOE hospital when her breast cancer recurred in her liver in 2014. When she consulted a private oncologist, she was informed of life-saving drugs (Herceptin and Kadcyla) that have kept her alive since then. She has spent close to RM177,200 (now 81 cycles) with the assistance of a compassionate programme, and after seven years, she continues to pay for lifelong treatment. She has since retired this year and leads a very active, fulfilling life. This is not acceptable for any contributing member of society to have lives cut short if not for these life-saving drugs.
In PCSM, some of their patient members have their lives unnecessarily shortened due to overpricing of medicines. Some medicines are so costly that only the wealthy could afford them, leaving the majority of the patients either facing financial catastrophe or opting out. PCSM recognise that the cost could be flexible among the drug manufacturers, as the cost price for the drug is just a fraction of the sale price, especially with drugs that have been in the market for a while but enjoy monopoly due to patents or only one or two generic suppliers. Also, there are equally efficacious generics elsewhere in the world in some cases, which could be obtained through limited supply personal imports.
Unfortunately, with wholesalers and retailers' current 'middleman' system, the markups at different levels would likely 'eat up' the supposed savings for the patients and families. Just to give one example, prostate cancer has an efficacious drug called Abiraterone acetate, priced at RM7,500 per month originally. PCSM fought hard for years to get accessibility of cheaper generics. Finally, a generic came to Malaysia two years ago, promising a lower price, but since it was a monopolised market, it was priced at RM4,000 (although it costs only RM800 in India). PCSM appealed to MOH to get a second generic. Before the generics arrived in Malaysia, PCSM had negotiated directly with the manufacturer as their members could only afford RM1,400. The manufacturer agreed and brought down the market price to the more affordable level exclusively for their members. But the other Malaysians are not so lucky. They have to go to the 'common market', either in the public or private hospital, where the costs range from RM2,400 to RM3,500. This shows the significant massive extent of the markup to the final price. PCSM has more than 50 members using the second generic, and the numbers are growing. From their experience in Malaysia with 350 prostate cancer survivors, some members managed to extend their lives and quality of living by an average of two years. How can anyone object to the regulation of markups that can prolong lives?
The lesson from the abovementioned stories is that patient advocacy organisations such as TAC and PCSM play a vital direct role in safeguarding the best interest of the demand side (the patients). Reducing the wholesalers and retailers' markups can achieve more affordable or favourable medicine pricing. Also, the Abiraterone acetate story told us, generic competition is the key to bringing affordable medicines to the patients.
For Phase 1 of MRP, only prescription drugs with a single registration holder in the Malaysian market (about 600 drugs) will be subjected to MRP, as single-sourced medications are usually most expensive due to market monopoly. Phase 1 will be monitored and reviewed before proceeding to the next phase. Transparency of the pricing that will be compared to external pricing of countries with similar GDP is good practice to ensure reasonable pricing for the patients in Malaysia. That is fair to the industry and private healthcare sector, which MOH always consults.
Therefore, we call for the government to implement the 1st phase of the MPR as soon as possible and urge the proponents of the CBA 2.0 to re-focus on implementing the 1st phase in line with the CBA 1.0. Stop using the victim card and stop exaggerating the numbers to include drugs outside Phase 1 in the CBA 2.0 study. If they genuinely care for their patients, the private healthcare industry also shouldn't make excessive profits at the expense of the patients, forcing them to fall into financial catastrophe or impoverishment. Instead, they should comply and lower their markup margin for costly drugs while still making a reasonable profit while changing their strategy to provide access to all patients, hence earning more by increased sales volume. Furthermore, it is reassuring that Europe, Australia, New Zealand, Canada, Indonesia, Thailand, India and China practice medicine price control.
We, the cancer patients, are very hopeful that cancer drugs can be made more affordable. Hence, we hope with regulated price control, more people can access and, through the economy of scale, bring reasonable profits to all parties.
Endorsed by:
1) Together Against Cancer (TAC)
2) Prostate Cancer Society Malaysia (PCSM)
3) Academy of Medicine Malaysia (AMM)
4) Breast Cancer Welfare Association Malaysia (BCWA)
5) Cancer Survivors Malaysia (CSM)
6) Cancer Survivor Support Group (CSSG)
7) Colorectal Cancer Survivorship Society Malaysia (Corum)
8) Kanwork
9) Majlis Kanser Nasional (MAKNA)
10) Malaysian Society of Haematology
11) National Cancer Society Malaysia (NCSM)
12) Persatuan Sukarelawan Kanser Negeri Kedah
13) Pink Ribbon Wellness (L) Foundation (PRWF)
14) Society for Cancer Advocacy & Awareness Kuching (SCAN)
15) The Max Foundation
16) War on Cancer
2) Prostate Cancer Society Malaysia (PCSM)
3) Academy of Medicine Malaysia (AMM)
4) Breast Cancer Welfare Association Malaysia (BCWA)
5) Cancer Survivors Malaysia (CSM)
6) Cancer Survivor Support Group (CSSG)
7) Colorectal Cancer Survivorship Society Malaysia (Corum)
8) Kanwork
9) Majlis Kanser Nasional (MAKNA)
10) Malaysian Society of Haematology
11) National Cancer Society Malaysia (NCSM)
12) Persatuan Sukarelawan Kanser Negeri Kedah
13) Pink Ribbon Wellness (L) Foundation (PRWF)
14) Society for Cancer Advocacy & Awareness Kuching (SCAN)
15) The Max Foundation
16) War on Cancer
* Together Against Cancer (TAC) is motivated to provide a unified voice for all cancer patients, to improve access to high quality healthcare in Malaysia through health policy and legislative reforms. Prostate Cancer Society Malaysia (PCSM) represents a Blue Ribbon Movement : Giving support to prostate cancer survivors through sharing & education; Educating public benefits of early detection & keeping them fit.
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