#WeAreNotWaiting for access and affordability

For the first time in history, we have a chance to make type 1 diabetes complications a thing of the past. There is an urgent need to put systems in place now to make sure hybrid closed looping technology is as accessible and affordable as possible.

One major barrier to uptake is the cost of continuous glucose monitoring (CGM).

MiyeongKimAndFamily

Here is the story of how one woman, inspired by the pioneers of the #WeAreNotWaiting movement, and driven by her fierce love for her three year old son, captured the hearts and minds of a nation. She gained government support, and helped turn South Korea from a country where children with diabetes were sometimes denied access to kindergarten, and people who purchased CGM supplies from foreign sources faced possible arrest, to one that now provides a 70% CGM subsidy for all with type 1 diabetes. The CGM subsidy came into effect on 1 January 2019.

Will South Korea be the only country to invest so fully in its people with diabetes? What steps can medical device companies, governments, insurance providers, diabetes organisations, and individuals around the world, put in place now to ensure a healthy future for all?

Miyeong Kim’s incredible story

[I have kept this in Miyeong Kim’s own words as much as possible, with only minor editing. From her post to the Facebook Looped group, November 2018. It is re-published here with Miyeong Kim’s permission.

– @T1Bionic]

My name is Miyeong Kim, and I am a mother to a boy with type 1 diabetes and the executive director of the Korean Society of Type-1 Diabetes.

In South Korea, there are approximately 40,000 people living with type 1 diabetes and the condition can be diagnosed early in childhood.

SonAtDiagnosis36Months
My son, Somyeong Jung, was diagnosed with type 1 diabetes at three years of age. It broke my heart to see how distraught he was when we gave him his injections and drew blood for his three hourly blood tests, so I looked for a better solution online.

At the time my son was diagnosed, Korea was falling behind global standards in diabetes management and the social treatment of people with diabetes. In 2015, several children were denied entrance to preschools. Families were told that blood glucose monitoring and administering insulin injections was too difficult.

We were emboldened and prompted to action by Nightscout’s motto, We are not waiting.

We banded together and called for a revised Childcare Act to protect our children from this discrimination. The revised Childcare Act was successfully passed in January 2016.

In 2014, our group heard that Freestyle Libre had been launched in Europe. Freestyle Libre and Dexcom products were not approved for sale in South Korea, so we felt we had no choice but to buy them from foreign sites for personal use.

We tried our best to communicate to the government that CGMs were life-changing for people with type one diabetes, not only because they were convenient, but also because they significantly lowered the risk of life-threatening complications.

We asked the government to approve importation of CGM and related devices and to sanction their coverage by public health insurance.

I was brought in for investigation seven times in 15 months by the Korean Customs Service and the Ministry of Food and Drug Safety, based on accusations made by an anonymous source that I had violated customs law and the medical appliances act. I avoided penalisation, but the process was incredibly nerve wracking and exhausting.

Even in the face of these difficulties, we could not bring ourselves to stop using CGMs.

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SonWithDexcomInArm

Our story was widely publicised and garnered public attention Many people showed their support for and solidarity with our cause.

ProtestAndPressConferenceMinistryForDrugSafety
We held a press conference and protest in front of the KFDA (Ministry of Food and Drug Safety) building in March 2018

Our predicament even reached the audience of president Moon Jae-in.

President Moon invited my child and me to a meeting where he promised to reform medical device regulation so that people with type 1 diabetes could reap the benefits of the latest products on the market.

The Medtronic Guardian Connect CGM was approved for use in February 2018, followed by the Dexcom G5 in July 2018. Reforms to the medical appliances law were made, providing a state-sanctioned guideline for individuals to freely purchase foreign-based medical appliances for personal use without fear of prosecution.

KimAndPresidentMoon
Miyeong Kim with her son and President Moon at the ‘Innovation of Medical Device Industry Regulation’ event, Bundang Seoul National University Hospital, 19th July 2018.

[In his speech at the Medical Device Innovation event, President Moon said Miyeong Kim’s story had caused him to reflect on the state of medical device innovation in Korea. He used the case to spearhead reforms to the Korean medical device industry. “We will create an industrial ecosystem that promotes the development of innovative medical technology,” President Moon said. www1.president.go.kr/articles/3881

“We will try to eliminate social prejudice against diabetes patients. It is also necessary to drastically reduce the period of time required for medical devices to enter the market and drastically reduce the barriers to entry.”

– @T1Bionic]

CGM reimbursement

As of 1 January of 2019, people with type 1 diabetes in South Korea only pay 30% of the cost for CGM. Public health insurance covers the remaining 70%.

MiyeongKimsSonFishing

In order to share our journey with you, we thought it might be a good idea to provide an even more detailed chronological account of our activities (below).

It was our honour and privilege to adopt Nightscout’s inspirational model as our guide to success, and we share our story in the hopes of positively contributing, in any way we can, to a community to which we are eternally indebted.

[Thank you to Ben West for bringing Miyeong Kim’s story to my attention. In Ben’s words: “Let us all consider how we can unify our demands for trustworthy, high fidelity therapy that in adapting to our lifestyles allows us to return to the lives we want to pursue with the people and activities we love. Let us make the benefits we discover accessible to as many as possible.” @T1Bionic]

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Timeline of events in South Korea

March 2015 – began importing Freestyle Libre

Parents in our group, the Korean Society of Type-1 Diabetes, began buying Freestyle Libre devices from the UK. They were not licensed for sale in the Korea at the time,

December 2015 – began importing Dexcom

Dexcom, similarly, was not licensed, but parents in the group began purchasing them from Czech sites.

January 2016 – Legislation of Childcare Act to protect children with type 1 diabetes

A revised Childcare Act was passed to ensure that children with type-1 diabetes were not discriminated against when competing for entrance into preschools. The act also dictated that permanently employed medical professionals be available in preschool institutions to administer insulin injections to children who need assistance throughout the day.

January-February 2016 –  campaigned for, and attended policy hearings pertaining to, the legislation of a revised School Healthcare Act

Our group campaigned for a revised School Healthcare Act that would allow diabetic students in elementary, middle, and high school to receive assistance of the school’s medical professional (i.e. the school nurse) when administering insulin/glucagon injections.

March 2017- charged by the Korean Customs Service

The group was subjected to investigation by the Korean Customs Service for purchasing CGM products from foreign sites without reporting to customs.

I was investigated by prosecutors and by customs for 4 months. I got the verdict that I was not guilty because I had not gained any profits from the activities and because mainstream Korean doctors, the Korean Paediatric Diabetes Association, the Korean Diabetes Association, and about 600 members (Type 1 Diabetes patients and caregivers) pleaded for me.

In the end, the prosecution dropped all charges in July, but the case was widely reported on and grabbed the attention of the public and the government, prompting them to question why we were led to purchase such products from foreign sites in the first place.

August 1, 2017 – A positive response from Dexcom

Once or twice a year, after we started using CGM, we sent a request to Dexcom’s US Headquarters, asking them to launch Dexcom CGM in Korea.

We received negative answers repeatedly due to Korea’s low marketability based on the small population of people here with type 1 diabetes.

However, when we communicated with Dexcom about our experience with the Korean prosecutors for importing Dexcom from overseas, we received a positive answer from Dexcom. The Vice President of Dexcom visited Korea on September 1, 2017, and since then he has visited Korea several times and prepared to launch. As part of the process, we assisted with a Korean diabetes market analysis, and arranged meetings with medical staff.

Finally, on July 31, 2018, one year after our first email to Dexcom, Dexcom was approved in Korea and has been on sale since November 1st, 2018.

November 13, 2017 – Blue House (the Korean presidential residence) announces, ‘Type-1 Diabetic Children Protection Measures’

The Office for Government Policy Coordination released its report, ‘Measures to Protect Type-1 Diabetic Children,’ and officials from the Ministry of Health and Welfare (MHW), the National Health Insurance Service (NHIS), the Ministry of Education (ME), and the Ministry of Food and Drug Safety (MFDS) attended the conference to discuss specific policies.

One discussion centred on expanding the list of ‘insurance covered disposable medical appliances used by type-1 diabetics’ to include CGM sensors, insulin pump syringes, and syringe needles. In addition, the government also sought to provide a comprehensive solution to individuals personally and haphazardly purchasing CGMs from abroad.

December 1, 2017 – charged by the Ministry of Food and Drug Safety (MFDS)

Even after charges levelled against us pertaining to customs violation were dropped, new accusations of medical appliances law violation were made against the group. I was brought in for, and subjected to, further investigations, which led to the case drawing even more media attention, forcing the MFDS to address again the fundamental problem that had led us to purchase CGMs from sites abroad.

March 6, 2018, held press conference in front of the MFDS headquarters

The group held a press conference to publicly denounce the actions of MFDS and appeal for policies centred on patient welfare, rather than punishing patients for attempting to access superior medical appliances unavailable in the country.

March 28, 2018, National Assembly Debate

Representatives of our group attended a National Assembly Debate and requested that the MFDS, MHW, and NHIS work together to streamline the complicated process that individual consumers have to go through in order to purchase medical appliances available only abroad, and further requested that such appliances be covered by national insurance.

The MFDS promised to establish and put forth a straightforward guideline, which was previously near nonexistent, for individuals who wish to purchase foreign appliances, and further to facilitate the importation of appliances high in demand for the convenience of Korean customers.

April 24, 2018 – Conference with the NHIS and the MHS

At the conference, the government announced that people with type 2 diabetes who need insulin injections more than three times a day would be subject to the same insurance coverage as people with type 1 diabetes, with the current standard being KRW 2,500 (US$2.20) per day.

While previously insurance coverage for type 1 diabetes was limited to four items (insulin syringes, injection needles, blood lancet, and blood glucose test strips), the list was amended at the conference to extend coverage to continuous glucose monitoring (CGM) sensors, automatic insulin pumps, and insulin pump needles, covering in total seven subcategories. While there was promise of expansion of coverage, the when, where, and who of the proposed expansion were not clearly decided upon at the time.

May 25, 2018 – Conference with NHIS

It was announced during the conference that CGMs would not be included in the list of disposable appliances for type-1 diabetes and would instead be covered independently so that coverage may be extended to the entire diabetic population.

The decision was based on the NHIS’s survey of the nation’s wider diabetic population, distributed through various patient groups, including our type 1 diabetes patient support group.

May 29, 2018 – Cheongwadae ‘Type-1 Diabetic Children Protection Measures’ Evaluation Meeting

The meeting was held to discuss and evaluate the success of the ‘Type 1 Diabetic Children Protection Measures’ announced by the Office for Government Policy Coordination a year prior. The meeting was attended by officials from the MHW, the MFDS, the Ministry of Education, as well as expert medical personnel and representatives from patient groups. Among the issues evaluated was whether CGM devices were regularly and steadily provided to the diabetic population.

July 29, 2018 – Function to advocate for medical appliance regulation reforms

My child and I were invited to the event where president Moon mentioned our case in his speech calling for a wholesale reform of the current medical appliance regulations in order to prevent cases like ours, involving grievances arising from false or malicious accusations.

August 1, 2018 Onwards

Insulin pump syringes and syringe needles are now included in insurance covered medical expenses (without changes in purchase price/cost) for all people with diabetes.

August 21, 2018 – Insurance coverage of CGM sensors

We attended a conference held to consult patient groups about the insurance coverage of CGM sensors. We discussed the standard cost/price of sensors for the purposes of calculating insurance coverage, percentage of the cost to the individual, and the timeline for policy implementation.

  • Target population: People with type 1 diabetes
  • Criteria for diagnosis: consistent with the existing standard of diagnosis of type 1 diabetes (disorder code: E10x, insulin-dependent diabetes)
  • Coverage standard cost: It is planned to differentiate between CGM and FGM when establishing a standard price for insurance coverage. The following proposal is yet to be finalised. The proposed agenda stipulates setting a standard cost of KRW70,000 (US$62) per one CGM sensor/1 week and KRW70,000 (US$62) per one FGM sensor/2 weeks. According to this proposal, per every 4 weeks, CGM sensors would cost KRW280,000 (US$246.50) while FGM sensors would cost KRW140,000 (US$123.20) for the average patient.
  • Cost to individual patient: According to the proposed agenda, individuals will bear 30% of the total cost. Patient groups have appealed to limit the cost to individuals to 20%, as any more than that will prove to be a significant burden on the average patient.
  • Prescription:
    • Coverage of CGMs and FGMs will be prescribed independently of existing ‘disposable appliances’ prescriptions.
    • Prescriptions from physicians (general practitioners), paediatricians, and family medicine doctors will be accepted by the NHIS.
    • Period of time for prescriptions: within 90 days, which is consistent with existing guidelines (If the cost proves too high, then one may present several prescriptions within short time frames to fully take advantage of insurance coverage plan.)
    • The prescription should be made weekly, according to the actual use rate of each individual.
  • Approximate timeframe for insurance policy implementation: Between November 2018 and February 2019.

October 10, 2018 – We made a phone inquiry to NHIS about when CGM sensors would be covered by public insurance

We received a reply that the inspect of government offices that was taking place had delayed the National Health Insurance Policy Review, which is now scheduled to take place after November. This would mean that the earliest the policy could be implemented is December 2018.

October 17-21, 2018 – Type 1 Diabetes Awareness Musical ‘A Very Special Gift’ performed

Premiering in 2016, the musical ‘A Very Special Gift’ is a product of collaboration between myself and two other mothers from our group. All of the songs in the musical were composed by Misun Kim, and the screenplay was written by 이수who is also a cast member. Our intention was to raise public awareness of type 1 diabetes through a family-friendly, informative, and entertaining musical. The musical has amassed approximately 10,000 viewers so far.

Summary

We as a group of patients and family members worked hard for years in order to bring about a world more accepting and tolerant of people with diabetes and their struggles. We encountered many different difficulties, but fortunately such hardships proved also to be valuable opportunities to raise awareness among the general public, helping us achieve our goals in the end.

Our story has been written about 300 times in the news over the past two years. It has been introduced on radio and in a television lecture program.

Our initiative and objectives were borne out of the same spirit embodied in Nightscout’s memorable call to arms: ‘We are not waiting.’

We extend our sincerest gratitude to Nightscout for inspiring us to act, and we would like to offer our help and support to anywhere we may be of assistance. Please do not hesitate to contact us.

Miyeong Kim

News articles (just some of the over 300 published)

[연합뉴스TV] 8월부터 소아당뇨 인슐린펌프 주사기·바늘 건보적용

http://v.media.daum.net/v/20180719222847480

[중앙일보] “당뇨 아이 위해 해외서 혈당기 사왔다고 고발, 규제 반성한다”

http://v.media.daum.net/v/20180720005751746

[동아일보] 문재인 대통령, 혁신성장 시동.. 의료기기 규제부터 푼다

http://v.media.daum.net/v/20180720030048174

4. [동아일보] ‘소아당뇨 맘’ 사연에 문재인 대통령 “깊은 반성”

http://v.media.daum.net/v/20180720030123201